The Effect of Micronutrient Supplementation on Nutrition Status and Well-being

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.

Conditions

• Micronutrient Deficiencies

Interventions

DIETARY_SUPPLEMENT

Active Effervescent Powder

Participants receive a daily sachet of effervescent powder that is Orange flavored, containing multiple vitamins and minerals

DIETARY_SUPPLEMENT

Placebo Effervescent powder

Participants receive a daily sachet of effervescent powder that is Orange flavored containing no active ingredients

OTHER

Nutrition training and healthy lifestyle coaching

Participants receive Nutrition training and healthy lifestyle coaching

Sponsors & Collaborators

• University of Health and Allied Sciences

  collaborator OTHER

• HALEON

  collaborator INDUSTRY

• InnoNext Sarl

  lead INDUSTRY

Principal Investigators

• Francis B. Prof. Zotor, PhD · University of Health and Allied Sciences, Fred N. Binka School of Public Health (FNBSPH), Ghana

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-18

Primary Completion

2025-08-26

Completion

2025-08-26

Countries

• Ghana

Study Locations