Dietary SupplementsPhase 4NCT06654089

A Study Evaluating Quality of Life Parameters Following Use of Emergen-C

A Phase 4 study testing Emergen-C Core Super Orange Powder in people with Dietary Supplements, run by HALEON at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine how Emergen-C use can improve quality of life (QoL) in a real-world setting to help consumers and healthcare professionals understand the benefits of taking Emergen-C on a routine or daily basis. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Dietary Supplements
What is being tested?: Emergen-C Core Super Orange Powder
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 299 participants
Where: 1 siteUnited States
Study dates: 30 Oct 2024to 24 Feb 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participant's provision of a signed and dated electronic informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
Healthy adults, 18-64 years of age at the time of electronic consent (does not exclude any ethnicities, races, or gender identities).
Participant is seeking to improve their energy/less fatigue levels.
Participants whose baseline score is greater than or equal to (>=) 10 on the dimension of general fatigue of the MFI and a score >=3 for at least ten of the 20 questions of the MFI.
Participants who are willing and able to comply with all study related activities as shown in the Schedule of Activities.
Participants who reside in the United States (except for Hawaii and Alaska).
Participants who own a mobile device, tablet or computer with access to stable internet connection and are willing to use their device to complete study surveys and assessments.

Who cannot join

Participants who are either directly involved in the conduct of the study or a member of their immediate family; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
Participants who have participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
Participants who are pregnant, lactating, or plan to be pregnant or lactating during the course of the study (self-report).
Participants with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients.
Participants who are hypertensive or salt-sensitive should be excluded from this study.
Participants who report being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day).

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Participants who are unable to read and understand English.
Participants who report current and/or recent (up to 3 months ago) major illnesses and/ or major surgery.
Participants who report a planned surgery during the study duration.
Participants who report a diagnosis of heart failure, heart rhythm disturbances, severe liver disease, severe mental health diagnosis, or severe renal failure.
Participants who report taking medications (in the previous 21 days) that have well established moderate or severe interaction with any of the study product ingredients: Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 milligrams (mg) per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, Monoamine Oxidase Inhibitors (MAOIs), or thyroid products.
Participants who are currently taking a multivitamin or have taken a multivitamin in the past 30 days and are not willing to stop taking a multivitamin for the duration of the trial.
Participants who are currently taking other Vitamin C or B supplements or have taken Vitamin C or B supplements in the past 30 days and are not willing to stop taking other Vitamin C or B supplements for the duration of the trial.
Participants who are currently consuming energy drinks or energy shots or have consumed an energy drink or energy shot in the past 30 days and are not willing to stop consuming energy drinks and energy shots for the duration of the trial.
A participant who has previously been enrolled in this study.
A participant who, in the opinion of the investigator or delegate, should not participate in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lindus Health Limited
New York, New York, 10017

Other trials in United States

About this study

Official title: A Real-World Evidence Study Evaluating Quality of Life Parameters Following Use of Emergen-C

Read the detailed description

This will be a randomized, double-blinded, placebo-controlled clinical trial to evaluate the over-time effects of 12-weeks Emergen-C supplementation on QoL parameters in a real-world setting. This study will be entirely decentralized, and participants will not be required to physically attend any on-site visits. All study data will be collected remotely through a study platform using the participant's personal mobile device, tablet or computer. Sufficient participants will be screened to enroll approximately 300 eligible participants (approximately 150 participants per group) and approximately 240 participants are expected to complete the study (approximately 120 participants per group).

Conditions: Dietary Supplements
Being tested: Emergen-C Core Super Orange Powder, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Emergen-C Core Super Orange PowderDietary supplement
A dietary supplement powder containing vitamin C, zinc, vitamin B6, vitamin B12, folate, and manganese.
PlaceboDietary supplement
To ensure proper blinding, the placebo was formulated to be indistinguishable from Emergen-C in taste, appearance, and other sensory characteristics. The placebo therefore contained fructose, and the electrolytes potassium, magnesium, calcium, and sodium.

Study groups in NCT06654089
Study group	Role	What they receive
Emergen-C Core Super Orange Powder (Test Product)	Experimental	Participants will be instructed to take the study product as per label instructions. Participants will consume one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. Receives: Dietary Supplement: Emergen-C Core Super Orange Powder
Placebo (Reference Product)	Placebo comparator	Participants will be instructed to take the study product as per label instructions. Participants will consume one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks. Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline and Week 12
Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline and Week 12
Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.
Measured: Baseline and Week 12
Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.
Measured: Baseline and Week 12
Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline and Week 12

Secondary outcomes (28)

Adjusted Mean Change From Baseline in MFI General Fatigue Domain Score at Weeks 4 and 8
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Weeks 4 and 8
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Weeks 4 and 8
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Weeks 4 and 8
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Weeks 4 and 8
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Fit
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel Only Able to do a Little
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Very Active
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Like Doing All Sorts of Nice Things
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Tired
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do a Lot in a Day
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: When I am Doing Something, I Can Keep my Thoughts on it
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Can Take on a Lot
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Dread Having to do Things
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do Very Little in a Day
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Can Concentrate Well
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I am Rested
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: It Takes a Lot of Effort to Concentrate on Things
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in a Bad Condition
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Have a Lot of Plans
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Tire Easily
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Get Little Done
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Don't Feel Like Doing Anything
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: My Thoughts Easily Wander
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in an Excellent Condition
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Measured: Baseline, Weeks 4, 8 and 12
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Family Support
Participants answered 2 QoL questions related to Family support domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.
Measured: Baseline, Weeks 4, 8 and 12
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Resilience
Participants answered 2 QoL questions related to resilience domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.
Measured: Baseline, Weeks 4, 8 and 12
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Ability to Relax and Unwind
Participants answered 2 QoL questions related to 'Ability to relax and unwind' domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.
Measured: Baseline, Weeks 4, 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 202424 Feb 2025

First posted23 Oct 2024
Study start30 Oct 2024
Primary completion24 Feb 2025
Study completion24 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dietary SupplementsStudies of the same condition, open and under way.
More trials run by HALEONThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06654089
Sponsor's protocol ID: 300217
Status last verified: Mar 2026
First submitted: 21 Oct 2024
Last updated: 7 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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Questions to ask the study team

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All Dietary Supplements trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Real-World Evidence Study Evaluating Quality of Life Parameters Following Use of Emergen-C
ClinicalTrials.gov ID: NCT06654089
Acronym / sponsor ID: 300217
Conditions: Dietary Supplements
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 299 participants (actual)
Lead sponsor: HALEONIndustry (pharma, biotech, devices)
Study start: 30 Oct 2024 (actual)
Primary completion: 24 Feb 2025 (actual)
Study completion: 24 Feb 2025 (actual)
First posted: 23 Oct 2024 (actual)
Results: Posted 10 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Emergen-C Core Super Orange Powder (Test Product)	Experimental	Dietary Supplement: Emergen-C Core Super Orange PowderParticipants will be instructed to take the study product as per label instructions. Participants will consume one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
Placebo (Reference Product)	Placebo comparator	Dietary Supplement: PlaceboParticipants will be instructed to take the study product as per label instructions. Participants will consume one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Participant's provision of a signed and dated electronic informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
Healthy adults, 18-64 years of age at the time of electronic consent (does not exclude any ethnicities, races, or gender identities).
Participant is seeking to improve their energy/less fatigue levels.
Participants whose baseline score is greater than or equal to (>=) 10 on the dimension of general fatigue of the MFI and a score >=3 for at least ten of the 20 questions of the MFI.
Participants who are willing and able to comply with all study related activities as shown in the Schedule of Activities.

Key exclusion criteria (16 listed)

Participants who are either directly involved in the conduct of the study or a member of their immediate family; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
Participants who have participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
Participants who are pregnant, lactating, or plan to be pregnant or lactating during the course of the study (self-report).
Participants with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients.
Participants who are hypertensive or salt-sensitive should be excluded from this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Emergen-C Core Super Orange PowderA dietary supplement powder containing vitamin C, zinc, vitamin B6, vitamin B12, folate, and manganese.	Dietary supplement	Emergen-C Core Super Orange Powder (Test Product)
PlaceboTo ensure proper blinding, the placebo was formulated to be indistinguishable from Emergen-C in taste, appearance, and other sensory characteristics. The placebo therefore contained fructose, and the electrolytes potassium, magnesium, calcium, and sodium.	Dietary supplement	Placebo (Reference Product)

Primary outcome

Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12
Time frame: Baseline and Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Week 12
Time frame: Baseline and Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Week 12
Time frame: Baseline and Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.
Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Week 12
Time frame: Baseline and Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.
Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Week 12
Time frame: Baseline and Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

28 secondary outcomes

Adjusted Mean Change From Baseline in MFI General Fatigue Domain Score at Weeks 4 and 8
Time frame: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Weeks 4 and 8
Time frame: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Weeks 4 and 8
Time frame: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Weeks 4 and 8
Time frame: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Weeks 4 and 8
Time frame: Baseline, Week 4 and Week 8
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Fit
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel Only Able to do a Little
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Very Active
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Like Doing All Sorts of Nice Things
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Tired
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do a Lot in a Day
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: When I am Doing Something, I Can Keep my Thoughts on it
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Can Take on a Lot
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Dread Having to do Things
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do Very Little in a Day
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Can Concentrate Well
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I am Rested
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: It Takes a Lot of Effort to Concentrate on Things
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in a Bad Condition
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Have a Lot of Plans
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Tire Easily
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Get Little Done
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Don't Feel Like Doing Anything
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: My Thoughts Easily Wander
Time frame: Baseline, Weeks 4, 8 and 12
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in an Excellent Condition
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Family Support
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Resilience
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Ability to Relax and Unwind
Time frame: Baseline, Weeks 4, 8 and 12

Results and safety

Results posted to the registry on 10 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Emergen-C Core Super Orange Powder (Test Product)	149	146
Placebo (Reference Product)	150	147

Primary outcome: Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: score on a scale

Measure	Emergen-C Core Super Orange Powder (Test Product) n = 146	Placebo (Reference Product) n = 147
Value	-5.23 (0.29)	-5.48 (0.29)

Emergen-C Core Super Orange Powder (Test Product) vs Placebo (Reference Product): Adjusted Mean Difference: 0.25 (95% CI -0.56 to 1.06), p = 0.5472, Mixed Model with Repeated Measures

Population analysed: The modified Intention-To-Treat (mITT) population consisted of all participants who were randomized, completed the Baseline visit, completed at least one-post Baseline MFI domain assessment, and took at least one dose of their allocated randomized product. Only those participants with data available at the specified time point were analyzed.

Primary outcome: Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Week 12

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: score on a scale

Measure	Emergen-C Core Super Orange Powder (Test Product) n = 146	Placebo (Reference Product) n = 147
Value	-3.75 (0.27)	-3.95 (0.26)

Emergen-C Core Super Orange Powder (Test Product) vs Placebo (Reference Product): Adjusted Mean Difference: 0.20 (95% CI -0.54 to 0.93), p = 0.6019, Mixed Model with Repeated Measures

Population analysed: mITT population. Only those participants with data available at the specified time point were analyzed.

Primary outcome: Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Week 12

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: score on a scale

Measure	Emergen-C Core Super Orange Powder (Test Product) n = 146	Placebo (Reference Product) n = 147
Value	-3.68 (0.28)	-3.96 (0.28)

Emergen-C Core Super Orange Powder (Test Product) vs Placebo (Reference Product): Adjusted Mean Difference: 0.28 (95% CI -0.49 to 1.05), p = 0.4732, Mixed Model with Repeated Measures

Population analysed: mITT population. Only those participants with data available at the specified time point were analyzed.

Primary outcome: Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Week 12

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: score on a scale

Measure	Emergen-C Core Super Orange Powder (Test Product) n = 146	Placebo (Reference Product) n = 147
Value	-3.83 (0.26)	-4.09 (0.26)

Emergen-C Core Super Orange Powder (Test Product) vs Placebo (Reference Product): Adjusted Mean Difference: 0.26 (95% CI -0.48 to 0.99), p = 0.4936, Mixed Model with Repeated Measures

Population analysed: mITT population. Only those participants with data available at the specified time point were analyzed.

28 secondary outcomes are reported in the full results.

Adverse events

Time frame: Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Emergen-C Core Super Orange Powder (Test Product)	0 of 147 (0%)	3 of 147 (2%)	0 of 147
Placebo (Reference Product)	0 of 150 (0%)	8 of 150 (5.3%)	0 of 150

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Emergen-C Core Super Orange Powder in people with Dietary Supplements, run by HALEON at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12 (time frame: Baseline and Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06654089.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.