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

NCT07031973 | Completed Phase 3

• 2 other identifiers: PACTR202402872415588UHAS-REC L.7 16123-24
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Assess the effect of micronutrient supplement with or without additional NuTHLiC on participants lifestyle habits and overall well- being through targeted questionnaires.

Conditions

Micronutrient Deficiencies

Keywords

Micronutrient deficiencies; Hidden Hunger; Sub-Saharan Africa

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to endpoint data collection, the time frame is 24 weeks

Secondary Outcomes (5)

• Number of participants with improved vitamin B12 status

  Time Frame: From baseline to endpoint data collection, the time frame is 24 weeks

• Number of participants with improved serum zinc status

  From baseline to endpoint data collection, the time frame is 24 weeks

• Number of participants with improved serum magnesium status

  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: 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

  From baseline to endpoint data collection, the time frame is 24 weeks

Study Arms (3)

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

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

Dietary Supplement: Active Effervescent Powder

Placebo Arm (Arm 3)

PLACEBO COMPARATOR

Participants receive a daily placebo Investigational Product for 24 weeks

Dietary Supplement: Placebo Effervescent powder

Interventions

Active Effervescent Powder DIETARY_SUPPLEMENT

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

Active Ingredient Arm (Arm 2); Training and Active Ingredient Arm (Arm 1)

Placebo Effervescent powder DIETARY_SUPPLEMENT

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

Placebo Arm (Arm 3)

Nutrition training and healthy lifestyle coaching OTHER

Participants receive Nutrition training and healthy lifestyle coaching

Training and Active Ingredient Arm (Arm 1)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• InnoNext Sarl: lead
• University of Health and Allied Sciences: collaborator
• HALEON: collaborator

Study Sites (1)

University of Health and Allied Sciences, Fred N. Binka School of Public Health

Hohoe, Volta Region, 00233, Ghana

Location

Study Officials

• Francis B. Prof. Zotor, PhD

  University of Health and Allied Sciences, Fred N. Binka School of Public Health (FNBSPH), Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Arm 1: single blinded (Study participants unaware if active or placebo Investigational Product) Arm 2: double blinded Arm 3: double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: June 22, 2025
• Study Start: February 18, 2025
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)