The Effect of Micronutrient Supplementation on Nutrition Status and Well-being
The Effect of Micronutrient Supplementation on Nutrition Status and Well-being
NCT ID: NCT07031973 Phase: PHASE3 Status: COMPLETED Enrollment: 150 Completion: 2025-08-26
Conditions
Micronutrient Deficiencies
Interventions
Active Effervescent Powder, Placebo Effervescent powder, Nutrition training and healthy lifestyle coaching
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:
- 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.
Primary Outcome
Number of participants with improved Vitamin D status