Micronutrient DeficienciesPhase 3NEXUSNCT07031973
The Effect of Micronutrient Supplementation on Nutrition Status and Well-being
A Phase 3 study testing Active Effervescent Powder and Nutrition training and healthy lifestyle coaching in people with Micronutrient Deficiencies, run by InnoNext Sarl at 1 site in Ghana.
Trial summary
Inadequate micronutrient status poses a significant challenge in Sub-Saharan African countries, including Ghana, and affects various demographics. The aim of the intervention study is to assess nutritional status and well-being through micronutrient supplementation with or without the combination of nutrition training… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Micronutrient Deficiencies
- What is being tested?
- Active Effervescent Powder and Nutrition training and healthy lifestyle coaching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGhana
- Study dates
- 18 Feb 2025to 26 Aug 2025
- Phase
- Phase 3
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy students in their second and third years of study at University of Health and Allied Sciences, Fred N. Binka School of Public Health
- Females and males aged 18 - 25 years
- Agree to remain in the study area for the 26-week period of the follow-up
- Gives written informed consent
- For female participants with childbearing potential:
- No plan to get pregnant the next 7 months (Acceptance of the requirement to use a highly effective form of birth control (herein referred to as condom) effective from consenting until at least week 24 after the final intake of Investigational Product (Month 6 visit).
Who cannot join
- Individuals taking routine micronutrient supplements
- History of food allergies
- Sensitivity to micronutrient supplement consumption and to any compositions of the micronutrients
- For females of child-bearing potential: pregnant as per serum pregnancy testing, or planning to become pregnant.
- Taking medications that could interact with the micronutrient supplements. Key medications which deplete the absorption of micronutrients include acid-suppressing and antacids, antiepileptic drugs (anti-convulsants), antibiotics, hormone replacement therapy (estrogens), digoxin, anti-inflammatory/analgesics
- Interested persons with severe anaemia (hemoglobin less than 7g/dl), as identified in the screening phase, will not be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
Ghana1 site
University of Health and Allied Sciences, Fred N. Binka School of Public Health
Hohoe, Volta Region, 00233
About this study
Official title: The Effect of Micronutrient Supplementation in Combination With Healthy Lifestyle Coaching on Nutrition Status and Well-being: A 6-Month Intervention Study in Ghana
Inadequate micronutrient status poses a significant challenge in Sub-Saharan African countries, including Ghana, and affects various demographics. The aim of the intervention study is to assess nutritional status and well-being through micronutrient supplementation with or without the combination of nutrition training and healthy lifestyle coaching among young adults in Ghana.
The outcomes the study is assessing are:
Read more
PRIMARY OUTCOME:
The primary outcome of this study is to determine if micronutrient supplement improves the vitamin D status of the study participants with or without additional Nutrition Training and Healthy Lifestyle Coaching. Vitamin D status will be assessed as serum 25(OH) D in serum.
SECONDARY OUTCOMES:
The secondary objectives are to:
- determine if the provision of micronutrient supplement with or without additional NuTHLiC improves participants serum levels of vitamin B12, serum zinc, serum magnesium, serum ferritin and red blood cell Hb.
- Assess the effect of micronutrient supplement with or without additional NuTHLiC on participants lifestyle habits and overall well- being through targeted questionnaires.
TRIAL DESIGN: This study is a 3-arm blinded randomized placebo-controlled trial among 151 young adults
participants in Arm 1 receive a daily Investigational Product and attend nutrition training and healthy lifestyle coaching;
participants in Arm 2 will receive an active Investigational Product;
participants in Arm 3 will receive a placebo Investigational Product.
Main data collection, including blood sampling for nutritional status will take place at Baseline (Day 0), Midpoint (Month 3) and Endpoint (Month 6). In addition, all participants will fill in a digital diary.
Read the detailed description
This study is a 6-month intervention study to assess the effect of micronutrient supplementation in combination with healthy lifestyle coaching on nutrition status and well-being will improve nutritional status with or without the combination of nutrition training and healthy lifestyle coaching among young adults in Ghana.
The test product is an Effervescent powder that is Orange flavored containing multiple vitamins and minerals, in a single serving, packaged within a multi-layer structure foil sachet. Participants will be required to mix Effervescent powder with water before consumption.
The placebo is also an Effervescent powder that is Orange flavored, but without active components, packaged within a multi-layer structure foil sachet. The placebo will be packaged in a manner that it looks and feels just like the micronutrient supplement with the only difference being the absence of the active ingredient in the micronutrient supplement.
The primary outcome of this study is to determine if micronutrient supplement improves the vitamin D status of the study participants with or without additional Nutrition Training and Healthy Lifestyle Coaching (herein referred to as NuTHLiC), Vitamin D status will be assessed as serum 25(OH) D in serum.
The secondary objectives are to:
- determine if the provision of micronutrient supplement with or without additional NuTHLiC improves participants serum levels of vitamin B12, serum zinc, serum magnesium, serum ferritin and red blood cell Hb.
- Assess the effect of micronutrient supplement with or without additional NuTHLiC on participants lifestyle habits and overall well-being through targeted questionnaires
After consenting, blood samples will be taken for biochemical analyses and the participants will also be assessed through standardized questionnaires in addition to vitals and anthropometric measurements.
The primary analysis will be intention-to-treat analysis. We fit a linear mixed effect model involving a random effect of participants within treatment groups and fixed effects of time and their interactions. The treatment effects will be shown as the mean difference (95% CI) in the change in serum 25(OH)D concentration between intervention and control groups. Model assumptions will be checked by inspecting the residual and quantile-quantile plot. Difference-in-difference (DID) will be used to determine the effect of each micronutrient supplement between the treatment (intervention) groups and the control (placebo) group. Sub-group analysis will also be used to contrast the factorial analysis.
- Conditions
- Micronutrient Deficiencies
- Being tested
- Active Effervescent Powder, Placebo Effervescent powder, Nutrition training and healthy lifestyle coaching
- Keywords
- Micronutrient deficiencies, Hidden Hunger, Sub-Saharan Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Effervescent PowderDietary supplement
Participants receive a daily sachet of effervescent powder that is Orange flavored, containing multiple vitamins and minerals
Placebo Effervescent powderDietary supplement
Participants receive a daily sachet of effervescent powder that is Orange flavored containing no active ingredients
Nutrition training and healthy lifestyle coachingOther
Participants receive Nutrition training and healthy lifestyle coaching
| Study group | Role | What they receive |
|---|---|---|
| Training and Active Ingredient Arm (Arm 1) | Active comparator | Particiants receive a daily Investigational Product for 24 weeks plus Nutrition Training and Healthy Lifestyle Coaching Receives: Dietary Supplement: Active Effervescent Powder; Other: Nutrition training and healthy lifestyle coaching |
| Active Ingredient Arm (Arm 2) | Active comparator | Participants receive a daily active Investigational Product for 24 weeks Receives: Dietary Supplement: Active Effervescent Powder |
| Placebo Arm (Arm 3) | Placebo comparator | Participants receive a daily placebo Investigational Product for 24 weeks Receives: Dietary Supplement: Placebo Effervescent powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with improved Vitamin D status
It will be measured with biomarker sampling at baseline, midpoint and endpoint if micronutrient supplementation improves the vitamin D status of the study participants with or without additional Nutrition Training and Healthy Lifestyle Coaching. Thresholds for determining Vitamin D status are based on serum 25-hydroxyvitamin D levels.
Measured: From baseline to endpoint data collection, the time frame is 24 weeks
Secondary outcomes (5)
Number of participants with improved vitamin B12 status
It will be measured with biomarker sampling at baseline, midpoint and endpoint if micronutrient supplementation improves the status of Vitamin B12 of the study participants that will receive a micronutrient supplement with or without additional Nutrition Training and Healthy Lifestyle Coaching.
Measured: Time Frame: From baseline to endpoint data collection, the time frame is 24 weeks
Number of participants with improved serum zinc status
It will be measured with biomarker sampling at baseline, midpoint and endpoint if micronutrient supplementation improves the status of serum zinc of the study participants that will receive a micronutrient supplement with or without additional Nutrition Training and Healthy Lifestyle Coaching.
Measured: From baseline to endpoint data collection, the time frame is 24 weeks
Number of participants with improved serum magnesium status
It will be measured with biomarker sampling at baseline, midpoint and endpoint if micronutrient supplementation improves the status of serum magnesium of the study participants that will receive a micronutrient supplement with or without additional Nutrition Training and Healthy Lifestyle Coaching.
Measured: Time Frame: From baseline to endpoint data collection, the time frame is 24 weeks
Number of participants with improved serum ferritin and red blood cell Haemoglobin status
It will be measured with biomarker sampling at baseline, midpoint and endpoint if micronutrient supplementation improves the status of serum ferritin and red blood cell haemoglobin of the study participants that will receive a micronutrient supplement with or without additional Nutrition Training and Healthy Lifestyle Coaching.
Measured: Time Frame: From baseline to endpoint data collection, the time frame is 24 weeks
Number of participants reporting effectiveness of additional Nutrition Training and Healthy Lifestyle Coaching on their lifestyle habits and overall well-being
The effect of micronutrient supplementation with or without additional Nutrition Training and Healthy Lifestyle Coaching on participants' lifestyle habits and overall well- being will be measured through targeted questionnaires as per outcome 2. The following data collection tools are used: 1) Global physical activity questionnaire; 2) Lifestyles and Habits Questionnaire; 3) Depression Anxiety Stress Scale 21; 4) Short Item Form Survey; 5) Young Women Food Intake; 6) Food Insecurity Experience; 7) 7-day Dietary Habit Recall; 8) Non-alcoholic Sugar-Sweetened Beverage Intake; 9) Multidimensional Subjective Wellbeing (MSW); 10) Nutrition Training and Healthy Lifestyle questionnaire. Each questionnaire has a different scale. Each questionnaire will be evaluated separately...
Measured: From baseline to endpoint data collection, the time frame is 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start18 Feb 2025
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Micronutrient DeficienciesStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Arm 1 will receive the daily Investigational Product (it will not be disclosed to the study participant if they receive a micronutrient supplement or a placebo) together with regular Nutrition Training and Healthy Lifestyle coaching 2. Arm 2 will receive the daily micronutrient supplementation 3. Arm 3 will receive the daily placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoNext Sarl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Health and Allied Sciences, HALEON
- Responsible party
- Sponsor
- Investigators
- Francis B. Prof. Zotor, PhD, Principal investigator, University of Health and Allied Sciences, Fred N. Binka School of Public Health (FNBSPH), Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031973
- Sponsor's protocol ID
- PACTR202402872415588
- Other IDs
- UHAS-REC L.7 16123-24
- Acronym
- NEXUS
- Status last verified
- Nov 2025
- First submitted
- 15 Feb 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A Data sharing agreement (but not a formal IDP plan) was signed giving access to other researchers for academic, non-commercial purposes. It stipulates: 1. For the sole use of any and all academic, non-commercial research purposes, including communication and publication in scientific journals, the Sponsor grants the Chief Investigator and the Participating Institution a royalty-free, non-exclusive, worldwide, perpetual, non-transferable license to use all Data, suitably anonymized. 2. The Chief Investigator, shall not and shall procure that the Participating Institutions shall not, give access to the Data to any commercial organisation other than the Sponsor and the Supporting Funder during the term of this Agreement and for a period of five years from the date of completion of the Study without the prior written consent of the Sponsor. 3. The Sponsor and the Chief Investigator agree to inform in writing each other about all organisations to whom they grant access to the Data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Micronutrient Supplementation in Combination With Healthy Lifestyle Coaching on Nutrition Status and Well-being: A 6-Month Intervention Study in Ghana
- ClinicalTrials.gov ID
- NCT07031973
- Acronym / sponsor ID
- NEXUS / PACTR202402872415588
- Conditions
- Micronutrient Deficiencies
- Keywords
- Micronutrient deficiencies, Hidden Hunger, Sub-Saharan Africa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- InnoNext SarlIndustry (pharma, biotech, devices)
- Collaborators
- University of Health and Allied Sciences, HALEON
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 22 Jun 2025 (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.
Inadequate micronutrient status poses a significant challenge in Sub-Saharan African countries, including Ghana, and affects various demographics. The aim of the intervention study is to assess nutritional status and well-being through micronutrient supplementation with or without the combination of nutrition training and healthy lifestyle coaching among young adults in Ghana.
The outcomes the study is assessing are:
PRIMARY OUTCOME:
The primary outcome of this study is to determine if micronutrient supplement improves the vitamin D status of the study participants with or without additional Nutrition Training and Healthy Lifestyle Coaching. Vitamin D status will be assessed as serum 25(OH) D in serum.
SECONDARY OUTCOMES:
The secondary objectives are to:
- determine if the provision of micronutrient supplement with or without additional NuTHLiC improves participants serum levels of vitamin B12, serum zinc, serum magnesium, serum ferritin and red blood cell Hb.
- Assess the effect of micronutrient supplement with or without additional NuTHLiC on participants lifestyle habits and overall well- being through targeted questionnaires.
TRIAL DESIGN: This study is a 3-arm blinded randomized placebo-controlled trial among 151 young adults
participants in Arm 1 receive a daily Investigational Product and attend nutrition training and healthy lifestyle coaching;
participants in Arm 2 will receive an active Investigational Product;
participants in Arm 3 will receive a placebo Investigational Product.
Main data collection, including blood sampling for nutritional status will take place at Baseline (Day 0), Midpoint (Month 3) and Endpoint (Month 6). In addition, all participants will fill in a digital diary.
Detailed description
This study is a 6-month intervention study to assess the effect of micronutrient supplementation in combination with healthy lifestyle coaching on nutrition status and well-being will improve nutritional status with or without the combination of nutrition training and healthy lifestyle coaching among young adults in Ghana.
The test product is an Effervescent powder that is Orange flavored containing multiple vitamins and minerals, in a single serving, packaged within a multi-layer structure foil sachet. Participants will be required to mix Effervescent powder with water before consumption.
The placebo is also an Effervescent powder that is Orange flavored, but without active components, packaged within a multi-layer structure foil sachet. The placebo will be packaged in a manner that it looks and feels just like the micronutrient supplement with the only difference being the absence of the active ingredient in the micronutrient supplement.
The primary outcome of this study is to determine if micronutrient supplement improves the vitamin D status of the study participants with or without additional Nutrition Training and Healthy Lifestyle Coaching (herein referred to as NuTHLiC), Vitamin D status will be assessed as serum 25(OH) D in serum.
The secondary objectives are to:
- determine if the provision of micronutrient supplement with or without additional NuTHLiC improves participants serum levels of vitamin B12, serum zinc, serum magnesium, serum ferritin and red blood cell Hb.
- Assess the effect of micronutrient supplement with or without additional NuTHLiC on participants lifestyle habits and overall well-being through targeted questionnaires
After consenting, blood samples will be taken for biochemical analyses and the participants will also be assessed through standardized questionnaires in addition to vitals and anthropometric measurements.
The primary analysis will be intention-to-treat analysis. We fit a linear mixed effect model involving a random effect of participants within treatment groups and fixed effects of time and their interactions. The treatment effects will be shown as the mean difference (95% CI) in the change in serum 25(OH)D concentration between intervention and control groups. Model assumptions will be checked by inspecting the residual and quantile-quantile plot. Difference-in-difference (DID) will be used to determine the effect of each micronutrient supplement between the treatment (intervention) groups and the control (placebo) group. Sub-group analysis will also be used to contrast the factorial analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 1. Arm 1 will receive the daily Investigational Product (it will not be disclosed to the study participant if they receive a micronutrient supplement or a placebo) together with regular Nutrition Training and Healthy Lifestyle coaching 2. Arm 2 will receive the daily micronutrient supplementation 3. Arm 3 will receive the daily placebo
| Arm | Type | Receives |
|---|---|---|
| Training and Active Ingredient Arm (Arm 1) | Active comparator | Dietary Supplement: Active Effervescent Powder, Other: Nutrition training and healthy lifestyle coachingParticiants receive a daily Investigational Product for 24 weeks plus Nutrition Training and Healthy Lifestyle Coaching |
| Active Ingredient Arm (Arm 2) | Active comparator | Dietary Supplement: Active Effervescent PowderParticipants receive a daily active Investigational Product for 24 weeks |
| Placebo Arm (Arm 3) | Placebo comparator | Dietary Supplement: Placebo Effervescent powderParticipants receive a daily placebo Investigational Product for 24 weeks |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Apparently healthy students in their second and third years of study at University of Health and Allied Sciences, Fred N. Binka School of Public Health
- Females and males aged 18 - 25 years
- Agree to remain in the study area for the 26-week period of the follow-up
- Gives written informed consent
- No plan to get pregnant the next 7 months (Acceptance of the requirement to use a highly effective form of birth control (herein referred to as condom) effective from consenting until at least week 24 after the final intake of Investigational Product (Month 6 visit).
Key exclusion criteria (6 listed)
- Individuals taking routine micronutrient supplements
- History of food allergies
- Sensitivity to micronutrient supplement consumption and to any compositions of the micronutrients
- For females of child-bearing potential: pregnant as per serum pregnancy testing, or planning to become pregnant.
- Taking medications that could interact with the micronutrient supplements. Key medications which deplete the absorption of micronutrients include acid-suppressing and antacids, antiepileptic drugs (anti-convulsants), antibiotics, hormone replacement therapy (estrogens), digoxin, anti-inflammatory/analgesics
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 |
|---|---|---|
| Active Effervescent PowderParticipants receive a daily sachet of effervescent powder that is Orange flavored, containing multiple vitamins and minerals | Dietary supplement | Active Ingredient Arm (Arm 2), Training and Active Ingredient Arm (Arm 1) |
| Placebo Effervescent powderParticipants receive a daily sachet of effervescent powder that is Orange flavored containing no active ingredients | Dietary supplement | Placebo Arm (Arm 3) |
| Nutrition training and healthy lifestyle coachingParticipants receive Nutrition training and healthy lifestyle coaching | Other | Training and Active Ingredient Arm (Arm 1) |
Primary outcome
Number of participants with improved Vitamin D status
Time frame: From baseline to endpoint data collection, the time frame is 24 weeks
It will be measured with biomarker sampling at baseline, midpoint and endpoint if micronutrient supplementation improves the vitamin D status of the study participants with or without additional Nutrition Training and Healthy Lifestyle Coaching. Thresholds for determining Vitamin D status are based on serum 25-hydroxyvitamin D levels.
5 secondary outcomes
Number of participants with improved vitamin B12 status
Time frame: Time Frame: From baseline to endpoint data collection, the time frame is 24 weeks
Number of participants with improved serum zinc status
Time frame: From baseline to endpoint data collection, the time frame is 24 weeks
Number of participants with improved serum magnesium status
Time frame: Time Frame: From baseline to endpoint data collection, the time frame is 24 weeks
Number of participants with improved serum ferritin and red blood cell Haemoglobin status
Time frame: Time Frame: From baseline to endpoint data collection, the time frame is 24 weeks
Number of participants reporting effectiveness of additional Nutrition Training and Healthy Lifestyle Coaching on their lifestyle habits and overall well-being
Time frame: From baseline to endpoint data collection, the time frame is 24 weeks
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 14 Nov 2025.
- Individual participant dataSharing planned: No. A Data sharing agreement (but not a formal IDP plan) was signed giving access to other researchers for academic, non-commercial purposes. It stipulates: 1. For the sole use of any and all academic, non-commercial research purposes, including communication and publication in scientific journals, the Sponsor grants the Chief Investigator and the Participating Institution a royalty-free, non-exclusive, worldwide, perpetual, non-transferable license to use all Data, suitably anonymized. 2. The Chief Investigator, shall not and shall procure that the Participating Institutions shall not, give access to the Data to any commercial organisation other than the Sponsor and the Supporting Funder during the term of this Agreement and for a period of five years from the date of completion of the Study without the prior written consent of the Sponsor. 3. The Sponsor and the Chief Investigator agree to inform in writing each other about all organisations to whom they grant access to the Data.
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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.
Francis B. Prof. Zotor, PhD principal investigator
University of Health and Allied Sciences, Fred N. Binka School of Public Health (FNBSPH), Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active Effervescent Powder and Nutrition training and healthy lifestyle coaching in people with Micronutrient Deficiencies, run by InnoNext Sarl at 1 site in Ghana.
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 6 inclusion and 6 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 14 Nov 2025. 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 Ghana. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of participants with improved Vitamin D status (time frame: From baseline to endpoint data collection, the time frame is 24 weeks). 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 14 Nov 2025.