The Effect of Micronutrient Supplementation on Nutrition Status and Well-being (NCT07031973) | Clinical Trial Compass
CompletedPhase 3
The Effect of Micronutrient Supplementation on Nutrition Status and Well-being
Ghana150 participantsStarted 2025-02-18
Plain-language 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 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:
1. 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.
2. 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.
Who can participate
Age range
18 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with improved Vitamin D status
Timeframe: From baseline to endpoint data collection, the time frame is 24 weeks