Iron Deficiency (Without Anemia)NCT05257343
Efficacy of a Low Dose, Oral, Liquid Iron Supplement on Restoring Inadequate Blood Iron to Normal Levels
A study testing Liquid Iron Supplement (Blood Builder ®) in people with Iron Deficiency (Without Anemia), run by Applied Science & Performance Institute at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting constipating side-effects among healthy premenopausal women with non-anemic iron deficiency. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency (Without Anemia)
- What is being tested?
- Liquid Iron Supplement (Blood Builder ®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to 9 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female subjects > 18 years old
- Premenopausal (experiencing regular menstrual cycles)
- Hemoglobin > 11g/dL
- Serum ferritin < 70 ng/mL
- hs-CRP < 3 mg/L
- BMI 18 - 29.9 kg/m2
Show all 10Show fewer
- No intake of dietary supplements containing iron 30 days prior to enrollment
- Willing and able to give written informed consent
- Able to read, understand, sign and date the informed consent document (English only)
- Able and willing to comply with the schedule visit(s) and study requirements.
Who cannot join
- Currently taking (within the past 14 days) dietary supplements including, vitamins (any), minerals, protein shakes, vitamin water, other supplements
- History of gastrointestinal disorders that could lead to uncertain absorption of the study supplements, (i.e., inflammatory bowel disease, ulcerative colitis, Crohn's disease, colostomy, or eating disorder)
- History or current malignancy
- Receiving chemotherapy agents or radiation treatments
- Prior health issues showing high CRP or other inflammatory markers
- Pregnancy or has breast fed within 3 months prior to enrollment
Show all 23Show fewer
- BMI <18 or >25 kg/m2
- Diagnosis of a terminal illness
- Use of prescription medications that impact digestion (i.e., proton pump inhibitor medications, other)
- History of alcohol abuse
- History or current drug abuse
- History or current cigarette smoke (including vaping) within the past 14 days from the screening visit
- Insulin-dependent diabetes and/or metformin use
- Chronic kidney or liver disease
- Anemia
- Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, hepatitis B/C, HIV, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years, or other, which in the opinion of the investigator, such condition might be aggravated as a result of treatment
- The investigator feels that for any reason the subject is not eligible to participate in the study
- Use within 24 hours preceding enrollment of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia)
- History of uncontrolled cardiovascular disease (i.e., myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
- History, or current bleeding disorders (i.e., hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirement and/or record the necessary study measurements
- A family member of the investigator or an employee of the investigator
- Participation in any other investigational study within 30 days prior to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The Applied Science and Performance Institute
Tampa, Florida, 33607
About this study
Official title: Assessment of the Efficacy of a Low-Dose Iron Supplement in Restoring Iron Levels to Normal Range Without Promoting Constipation or Adverse Gastrointestinal Effects Among Healthy Premenopausal Women With Iron Deficiency Without Anemia
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting constipating side-effects among healthy premenopausal women with non-anemic iron deficiency. The primary outcomes will be an Iron Panel of Serum Iron, Ferritin, Total iron-binding capacity, Transferrin saturation, Complete Blood Count, and high sensitivity - C-Reactive Protein. Secondary outcomes will be surveys on gastrointestinal distress/discomfort and well-being. Adverse events will also be reported.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting constipating side-effects among healthy premenopausal women with non-anemic iron deficiency.
A total of 82 premenopausal female subjects over the age of 18 years old are planned for this study. Enrolled subjects will be assigned a unique study number in the 100 series as the subject ID for the study to maintain anonymity. The subject ID will be assigned in sequential order starting with 101 (i.e., 101, 102, 103, etc). After signing the informed consent document, enrolled subjects will be screened, and qualifying subjects will be randomly assigned to one of two groups (Group A or Group B) depending on the treatment (liquid iron supplement or placebo). Following random assignment, subjects will revisit the laboratory to complete baseline testing for primary, secondary, and exploratory outcomes. After 4 weeks of daily supplementation of their respective randomly assigned condition, subjects return to the laboratory for reassessment of secondary outcomes. The last laboratory visit will occur following 8 weeks of daily supplementation in which subjects will be reassessed on all outcomes in a manner identical to baseline.
GROUPS:
- Group A: Single-dose containing 10 mL of a liquid iron formulation to be ingested once a day on an empty stomach no sooner than 3 hours after consuming a meal.
- Group B: Single-dose containing 10 mL of the placebo formulation to be ingested once a day on an empty stomach no sooner than 3 hours after consuming a meal.
VISITS:
- Visit 1: Study enrollment and eligibility screening. Written informed consent will be obtained to confirm study enrollment prior to eligibility screening.
- Visit 2: Baseline assessment
- Visit 3: Reassess secondary variables only
- Visit 4: Reassess all measurements for final post-testing and end of study (EOS).
For laboratory visits requiring blood donation (visits 1, 2, and 4), subjects will arrive at the laboratory following an overnight fast (≥ 10 hours) and undergo standard sterile venipuncture techniques by a certified phlebotomist. Blood samples, approximately 10mL in volume, will be collected into a marble top (gel-barrier) tube interiorly coated with silicone. Following collection, samples will be inverted 4-6 times then stored upright at room temperature in a test tube holder for approximately 30 minutes to promote coagulation; thereafter, samples will be centrifuged for serum separation. The resulting serum aliquot will be immediately stored at -80°C until further analysis of blood chemistry variables.
For questionnaire assessments (Patient assessment of constipation - symptoms, functional bowel index, Gastrointestinal symptom rating scale, and abbreviated Profile of Mood States), subjects will complete the questionnaires in isolation in a quiet room isolated to avoid bystander influence. For visit 3, subjects are not required to be fasted. All study visits will be conducted at the same time of day (± 1 hour).
- Conditions
- Iron Deficiency (Without Anemia)
- Being tested
- Liquid Placebo Supplementation, Liquid Iron Supplement (Blood Builder ®)
- Keywords
- Iron Deficiency, Iron Supplementation, Premenopausal Women, Ferritin, Hematology
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Placebo SupplementationDietary supplement
8-weeks of supplementing with a visually identical liquid placebo supplement.
Liquid Iron Supplement (Blood Builder ®)Dietary supplement
8-weeks of supplementing with a liquid iron supplement (Blood Builder ®)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Daily dose (10 mL) of a visually identical liquid placebo supplement to be ingested on an empty stomach no sooner than 3 hours after consuming a meal. Receives: Dietary Supplement: Liquid Placebo Supplementation |
| Blood Builder Treatment | Experimental | Daily dose (10 mL) of liquid iron supplement (Blood Builder®) formulation to be ingested on an empty stomach no sooner than 3 hours after consuming a meal. Receives: Dietary Supplement: Liquid Iron Supplement (Blood Builder ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Iron
Changes in Iron in fasted serum blood samples.
Measured: Week 0 and Week 8
Serum Ferritin
Changes in Ferritin in fasted serum blood samples.
Measured: Week 0 and Week 8
Total Iron-Binding Capacity (TIBC)
Changes in TIBC in fasted serum blood samples.
Measured: Week 0 and Week 8
Transferrin Saturation (tSAT)
Changes in tSAT in fasted serum blood samples.
Measured: Week 0 and Week 8
Complete Blood Count (CBC)
Changes in complete blood count with differential will be assessed via fasted serum blood samples
Measured: Week 0 and Week 8
High Sensitivity C-Reactive Protein (hs-CRP)
Changes in hs-CRP in fasted serum blood samples.
Measured: Week 0 and Week 8
Secondary outcomes (5)
Patient Assessment of Constipation - Symptoms Questionnaire
Changes assessed by administering the Patient Assessment of Constipation - Symptoms questionnaire for subjective assessment of constipation symptoms. Each question is answered from 0 (no symptoms at all) to 4 (severe symptoms). The lower the mean score, the less severe the symptoms. The higher the mean score, the more severe the symptoms.
Measured: Week 0, Week 4, and week 8
Functional Bowel Index
Changes assessed by administering the Functional Bowel Index for subjective assessment of bowel movements. A 3 item questionnaire scored from 0-100 with higher scores indicating greater severity and scores higher than 28.8 points indicating constipation.
Measured: Week 0, Week 4, and week 8
Gastrointestinal symptom rating scale
Changes assessed by administering the Gastrointestinal Symptom Rating Scale for subjective assessment of gastrointestinal symptoms and their severity. It is a 15-item questionnaire designed to assess the symptoms associated with common GI disorders. It has 5 subscales (Reflux, Diarrhea, Constipation, Abdominal Pain, and Indigestion Syndrome). Subscale scores range from 1 to 7 and higher scores represent more discomfort, and lower scores represent less or even no discomfort.
Measured: Week 0, Week 4, and week 8
Abbreviated Profile of Mood States
Changes assessed in the abbreviated profile of mood states for subjective assessment of the subject's mood and overall well-being. It is a 40 point scale, divided into 7 different subscales, with a 5 point Likert scale, ranging from 0 (not at all) to 4 (Extremely) of how a subject feels in response to that particular feeling. The following equation is used to determine the overall score: Total Mood Disturbance = [Tension+Depression+Anger+Fatigue+Confusion] - [Vigor+Esteem Related Affect]. A lower score indicates overall better mood, while a lower score indicates worse overall mood.
Measured: Week 0 and Week 8
Adverse Events
Defined as participants self-reported adverse effects. Items that will be surveyed are headache, dizziness, nausea, vomiting, indigestion, blurred vision, lethargy, swelling, itching, chest pain, heart palpitations, difficulty breathing, lethargy, and muscle cramps.
Measured: Week 0, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start7 Feb 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency (Without Anemia)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, parallel, placebo-controlled, 8-week intervention clinical study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257343
- Sponsor's protocol ID
- MF121521
- Status last verified
- May 2023
- First submitted
- 4 Feb 2022
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of a Low-Dose Iron Supplement in Restoring Iron Levels to Normal Range Without Promoting Constipation or Adverse Gastrointestinal Effects Among Healthy Premenopausal Women With Iron Deficiency Without Anemia
- ClinicalTrials.gov ID
- NCT05257343
- Acronym / sponsor ID
- MF121521
- Conditions
- Iron Deficiency (Without Anemia)
- Keywords
- Iron Deficiency, Iron Supplementation, Premenopausal Women, Ferritin, Hematology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting constipating side-effects among healthy premenopausal women with non-anemic iron deficiency. The primary outcomes will be an Iron Panel of Serum Iron, Ferritin, Total iron-binding capacity, Transferrin saturation, Complete Blood Count, and high sensitivity - C-Reactive Protein. Secondary outcomes will be surveys on gastrointestinal distress/discomfort and well-being. Adverse events will also be reported.
Detailed description
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting constipating side-effects among healthy premenopausal women with non-anemic iron deficiency.
A total of 82 premenopausal female subjects over the age of 18 years old are planned for this study. Enrolled subjects will be assigned a unique study number in the 100 series as the subject ID for the study to maintain anonymity. The subject ID will be assigned in sequential order starting with 101 (i.e., 101, 102, 103, etc). After signing the informed consent document, enrolled subjects will be screened, and qualifying subjects will be randomly assigned to one of two groups (Group A or Group B) depending on the treatment (liquid iron supplement or placebo). Following random assignment, subjects will revisit the laboratory to complete baseline testing for primary, secondary, and exploratory outcomes. After 4 weeks of daily supplementation of their respective randomly assigned condition, subjects return to the laboratory for reassessment of secondary outcomes. The last laboratory visit will occur following 8 weeks of daily supplementation in which subjects will be reassessed on all outcomes in a manner identical to baseline.
GROUPS:
- Group A: Single-dose containing 10 mL of a liquid iron formulation to be ingested once a day on an empty stomach no sooner than 3 hours after consuming a meal.
- Group B: Single-dose containing 10 mL of the placebo formulation to be ingested once a day on an empty stomach no sooner than 3 hours after consuming a meal.
VISITS:
- Visit 1: Study enrollment and eligibility screening. Written informed consent will be obtained to confirm study enrollment prior to eligibility screening.
- Visit 2: Baseline assessment
- Visit 3: Reassess secondary variables only
- Visit 4: Reassess all measurements for final post-testing and end of study (EOS).
For laboratory visits requiring blood donation (visits 1, 2, and 4), subjects will arrive at the laboratory following an overnight fast (≥ 10 hours) and undergo standard sterile venipuncture techniques by a certified phlebotomist. Blood samples, approximately 10mL in volume, will be collected into a marble top (gel-barrier) tube interiorly coated with silicone. Following collection, samples will be inverted 4-6 times then stored upright at room temperature in a test tube holder for approximately 30 minutes to promote coagulation; thereafter, samples will be centrifuged for serum separation. The resulting serum aliquot will be immediately stored at -80°C until further analysis of blood chemistry variables.
For questionnaire assessments (Patient assessment of constipation - symptoms, functional bowel index, Gastrointestinal symptom rating scale, and abbreviated Profile of Mood States), subjects will complete the questionnaires in isolation in a quiet room isolated to avoid bystander influence. For visit 3, subjects are not required to be fasted. All study visits will be conducted at the same time of day (± 1 hour).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, parallel, placebo-controlled, 8-week intervention clinical study.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Liquid Placebo SupplementationDaily dose (10 mL) of a visually identical liquid placebo supplement to be ingested on an empty stomach no sooner than 3 hours after consuming a meal. |
| Blood Builder Treatment | Experimental | Dietary Supplement: Liquid Iron Supplement (Blood Builder ®)Daily dose (10 mL) of liquid iron supplement (Blood Builder®) formulation to be ingested on an empty stomach no sooner than 3 hours after consuming a meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy female subjects > 18 years old
- Premenopausal (experiencing regular menstrual cycles)
- Hemoglobin > 11g/dL
- Serum ferritin < 70 ng/mL
- hs-CRP < 3 mg/L
Key exclusion criteria (23 listed)
- Currently taking (within the past 14 days) dietary supplements including, vitamins (any), minerals, protein shakes, vitamin water, other supplements
- History of gastrointestinal disorders that could lead to uncertain absorption of the study supplements, (i.e., inflammatory bowel disease, ulcerative colitis, Crohn's disease, colostomy, or eating disorder)
- History or current malignancy
- Receiving chemotherapy agents or radiation treatments
- Prior health issues showing high CRP or other inflammatory markers
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 |
|---|---|---|
| Liquid Placebo Supplementation8-weeks of supplementing with a visually identical liquid placebo supplement. | Dietary supplement | Placebo |
| Liquid Iron Supplement (Blood Builder ®)8-weeks of supplementing with a liquid iron supplement (Blood Builder ®) | Dietary supplement | Blood Builder Treatment |
Primary outcome
Serum Iron
Time frame: Week 0 and Week 8
Changes in Iron in fasted serum blood samples.
Serum Ferritin
Time frame: Week 0 and Week 8
Changes in Ferritin in fasted serum blood samples.
Total Iron-Binding Capacity (TIBC)
Time frame: Week 0 and Week 8
Changes in TIBC in fasted serum blood samples.
Transferrin Saturation (tSAT)
Time frame: Week 0 and Week 8
Changes in tSAT in fasted serum blood samples.
Complete Blood Count (CBC)
Time frame: Week 0 and Week 8
Changes in complete blood count with differential will be assessed via fasted serum blood samples
High Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Week 0 and Week 8
Changes in hs-CRP in fasted serum blood samples.
5 secondary outcomes
Patient Assessment of Constipation - Symptoms Questionnaire
Time frame: Week 0, Week 4, and week 8
Functional Bowel Index
Time frame: Week 0, Week 4, and week 8
Gastrointestinal symptom rating scale
Time frame: Week 0, Week 4, and week 8
Abbreviated Profile of Mood States
Time frame: Week 0 and Week 8
Adverse Events
Time frame: Week 0, Week 4, and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
Related trials for Iron Deficiency (Without Anemia)
Active, not recruiting
Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency
Iron Deficiency (Without Anemia)
Not yet recruitingObservational study
Impact of Iron Deficiency on Arrhythmic Events and Resting ECG Abnormalities in Patients Hospitalized With Heart Failure
Heart Failure, Iron Deficiency
Recruiting
Risk of Anemia and Effects of Oral Iron Therapy in Non-Anemic Iron-Deficient Women (18-55 Years)
Non-Anemic Iron Deficiency
Active, not recruiting
The Immediate and Long-term Effects of a Novel Marine-based Iron Supplement in Adult Females
Anemia, Iron Deficiency (Without Anemia)
RecruitingObservational study
Non-invasive Detection of Iron Deficiency in Obstetrics
Iron Deficiency Anemia of Pregnancy, Iron-deficiency
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 study testing Liquid Iron Supplement (Blood Builder ®) in people with Iron Deficiency (Without Anemia), run by Applied Science & Performance Institute 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 10 inclusion and 23 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 30 May 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum Iron (time frame: Week 0 and Week 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2023.