Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402872415588 Date of Registration: 06/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of micronutrient supplementation in combination with healthy lifestyle coaching on nutrition status and well-being: A 6-month study in Ghana
Official scientific title The effect of micronutrient supplementation in combination with healthy lifestyle coaching on nutrition status and well-being: A 6-month study in Ghana
Brief summary describing the background and objectives of the trial Background Inadequate or suboptimal micronutrient status poses a significant challenge in Sub-Saharan African countries, including Ghana, and affects various demographics. The student population is of concern as the combination of high stress levels and unhealthy eating habits is considered to impact their nutritional status and well-being. The student population is representative for the active generation of young African adults living in an urbanized environment with nowadays lifestyle. Therefore, complementing nutritional guidance for a well-balanced diet, with micronutrient supplementation and coaching to promote healthier lifestyle and dietary choices and overall well-being, are considered necessary solutions to address these pressing issues. Main Objective To test the feasibility to improve the nutritional status and wellbeing through micronutrient supplementation with or without the combination with nutrition training and healthy lifestyle coaching in a setting of young adults enrolled in the University of Health and Allied Sciences (UHAS), Fred N. Binka School of Public Health (FNBSPH) in Ghana.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/10/2024
Actual trial start date
Anticipated date of last follow up 07/03/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Micronutrient supplementation together with regular Nutrition and healthy Lifestyle coaching Once daily Six (6) months In this 3-arm blinded randomized placebo-controlled trial, we will recruit 150 healthy male and female university undergraduate young adults aged 18-25 years who are students enrolled at the Fred Newton Binka School of Public Health (FNBSPH) in Hohoe, Ghana. The trial will have 3 arms that consist of 2 intervention arms and 1 control arm that has an average of 50 respondents per arm. In Arm 1 (single-blinded), participants will be randomized to receive daily micronutrient supplementation containing vitamins, minerals, and trace elements in form of effervescent powder complemented with specific nutrition training and healthy lifestyle coaching. 50
Experimental Group Micronutrient supplementation. Once daily Six (6) months In this 3-arm blinded randomized placebo-controlled trial, we will recruit 150 healthy male and female university undergraduate young adults aged 18-25 years who are students enrolled at the Fred Newton Binka School of Public Health (FNBSPH) in Hohoe, Ghana. The trial will have 3 arms that consist of 2 intervention arms and 1 control arm that has an average of 50 respondents per arm. Arm 2 will receive only the daily micronutrient supplementation. 50
Control Group Placebo Once daily Six (6) months In this 3-arm blinded randomized placebo-controlled trial, we will recruit 150 healthy male and female university undergraduate young adults aged 18-25 years who are students enrolled at the Fred Newton Binka School of Public Health (FNBSPH) in Hohoe, Ghana. The trial will have 3 arms that consist of 2 intervention arms and 1 control arm that has an average of 50 respondents per arm. Arm 3 will receive daily placebo 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● Apparently healthy students in their second and third-years of study ● Female and male aged 18 - 25 years ● Agree to remain in the study area for the 26-week period of the follow-up ● Gives written informed consent ● Individuals taking routine micronutrient supplements ● History of food allergies and sensitivity to micronutrient supplement consumption ● Sensitivities to any compositions of the micronutrients ● Pregnant students as per their last menstrual period ● 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 (Karadima et al, 2016) ● Cases of severe anaemia (hemoglobin less than 7 g/dl) Adult: 19 Year-44 Year 18 Year(s) 25 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 20/03/2024 UHAS ethics
Ethics Committee Address
Street address City Postal code Country
Sokode-Ho Ho PMB 31 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/05/2024 University of Health and Allied Sciences Research Ethic Committee
Ethics Committee Address
Street address City Postal code Country
PMB 31, Ho. Volta Region Ghana Ho 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total serum 25-hydroxyvitamin D (25(OH)D) Vitamin D will be the primary biomarker endpoint. It is the major circulating form of vitamin D in the blood. At endline, we expect to see a clinically significant increase in the baseline serum 25(OH)D among the intervention groups week 13 and week 26
Secondary Outcome A secondary outcomes that will be obtained through interviews are targeted at assessing the psychological wellbeing of the participants. The change from baseline to endline will include the levels of severity of depression, anxiety and stress and the subjective well being of the participants measured using the DASS-21 (Depression Anxiety Stress Scale) and the CSSW (College Student Subjective Wellbeing) questionnaires, respectively. 13 weeks and 26 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Health and Allied Sciences Fred N. Binka School of Public Health PMB 31 Hohoe Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Haleon Weybridge, Surrey, KT13 ONY. Surrey United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Innonext Chemin de rison 7,1817 Brent. Montreux Switzerland Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Francis Zotor fbzotor@uhas.edu.gh +2330241236389 Volta Regional Hospital
City Postal code Country Position/Affiliation
Hohoe Ghana Lecturer
Role Name Email Phone Street address
Principal Investigator Francis Zotor fbzotor@uhas.edu.gh +2330241236389 Volta Regional Hospital
City Postal code Country Position/Affiliation
Hohoe Ghana Lecturer
Role Name Email Phone Street address
Public Enquiries Francis Zotor fbzotor@uhas.edu.gh +2330241236389 Volta Regional Hospital
City Postal code Country Position/Affiliation
Hohoe Ghana Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data sharing in this study will prioritize confidentiality and anonymity. Personal and health-related data will be securely stored and accessed only by authorized personnel. Participants' identities will be protected, and data will be aggregated and anonymised when shared. Consent for data sharing will be obtained separately, following institutional guidelines and regulations. Informed Consent Form September-December 2025 The Chief Investigator will collect the Data from the Study Site according to the Protocol and provide the Data, suitably anonymized, to the Sponsor and the organisations designated by the Sponsor, within fourteen (14) days (or such other timeframe as is agreed in writing with the Sponsor) after such Data is recorded in the Study database after database freeze or at such time that the Chief Investigator provides the Data from the Study to a third party, whichever is the earliest date. The Data will be provided in such format as the Sponsor and the organisations designated by the Sponsor to the Chief Investigator may reasonably request. The Sponsor and the Supporting Funder may perform analysis of such Data as deemed appropriate and they may use such Data and analyses as they wish for internal purposes, which shall include, without limitation, disclosure to any third parties to the extent that they may be assisting the Sponsor and the Supporting Funder or its Affiliates with any analysis, subject to that third party agreeing to keep such Data and analyses confidential.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information