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.: PACTR202508843066542 Date of Registration: 11/08/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of a complementary feeding product rich in essential fatty acid and carotenoids on growth, cognition and vision in Ghanaian children
Official scientific title Complementary feeding product rich in essential fatty acids and carotenoids to improve growth, brain development and vision in Ghanaian children.
Brief summary describing the background and objectives of the trial Child undernutrition is a global health concern affecting physical and intellectual capabilities. Undernutrition in Northern Ghana shows 30% of children below 5 years are stunted. There is evidence that children have cognition and ocular health deficits. Our previous research shows children in Northern Ghana suffer essential fatty acid (EFA) deficiency and vitamin A deficiency(VAD). In spite of interventions, the situation persists. It is against this backdrop that this project seeks to evaluate the efficacy of a complementary feeding product that is fortified with essential fatty acids and carotenoids to be incorporated into complementary food to improve cognition and ocular health and growth. Fortified biscuits will be produced and fed to children in a randomized controlled trial (RCTs). Children fed with the biscuits will have adequate levels of EFAs and carotenoids with improved nutrition status. Long term impacts include improved cognition, vision and growth.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CFPEFAC
Disease(s) or condition(s) being studied undernutrition, micronutrient deficiency, cognitive delay and nutrition-related visual impairment
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 18/08/2025
Actual trial start date
Anticipated date of last follow up 30/01/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
4500476459 Organization of Women in Science in Developing World-UNESCO
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 Sealed opaque envelopes 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 Complementary feeding product rich in essential fatty acids and carotenoids Forty grams (40g) of biscuits contains 41.6% orange-fleshed sweet potato, 41.6% soybean, 6.6% yellow corn and 2% flaxseed. Five days a week, for 24 weeks A locally formulated complementary feeding product (biscuits) designed for Ghanaian children aged 3-6 years. It is fortified with essential fatty acids from local sources (omega-3 fatty acids) and carotenoids (yellow corn, orange fleshed sweet potatoes0, and aims to support growth, vision and cognition 50
Control Group Standard complementary feeding biscuit Forty grams of a placebo biscuit wmade of wheat flour and vegetable oil, without orange fleshed sweet potato, flax seeds, soybean and yellow maise Five days in a week for 24 weeks Biscuits without active ingredients- soybean, orange-fleshed sweet potato, flax seed and yellow corn will be fed wto children 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy children with no chronic condition or physical or mental disabilities. Children not intending to use micronutrient supplements during the duration of the study. Caregivers and children planning to reside in the area in the next 6 months Sick and hospitalised children Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 6 Year(s) Both
ETHICS APPROVAL
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cognitive development At baseline and at 24 weeks end of intervention
Secondary Outcome Linear growth At baseline and at the end of 24 weeks end of intervention
Secondary Outcome Vision At baseline and at 24 weeks- end of intervention
Secondary Outcome Serum Vitamin A At baseline and at 24 weeks -end of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bunglung Community Health Post Bunglung Community Savelugu Municipal 00233 Ghana
Pong Tamale Community Health Post Pong Tamale Community Savelugu Municipal 00233 Ghana
Morglaa Community Health Post Morglaa Community Savelugu Municipal 00233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Organization of Women in Science in Developing World of UNESCO The World Academy of Sciences TWAS, ICTP Campus, Strada Costiera 11, 34151, Trieste, Italy Trieste 34151 Italy
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Not applicable n/ANot applicable Not applicable Ghana Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Jenifer Fenton Department of Food Science and Human Nutrition East Lansing 48824 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mary Amoako madjepong@knust.edu.gh 0246410959 College of Science, PMB. KNUST.
City Postal code Country Position/Affiliation
Kumasi 0233 Ghana Senior LecturerKwame Nkrumah University of Science and Technology
Role Name Email Phone Street address
Public Enquiries Abena Boakye abenaachiaaboakye@knust.edu.gh 0244826613 College of Science, KNUST. PMB
City Postal code Country Position/Affiliation
Kumasi 0233 Ghana Senior Lecturer..Kwame Nkrumah University of Science and Technology
Role Name Email Phone Street address
Scientific Enquiries Kwadwo Owusu Akuffo koakuffo@gmail.com 0507315144 College of Science, KNUST, PMB
City Postal code Country Position/Affiliation
Kumasi 0233 Ghana Senior Lecturer..Kwame Nkrumah University of Science and Technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (including demographic data, cognitive scores, growth measurements, and vision assessments) will be made available upon reasonable request after publication of main findings. Data will be shared with researchers for academic purposes under a data sharing agreement. Informed Consent Form De-identified individual participant data will be made available for up to up 5 years following publication Access will be granted to qualified researchers for commercial, academic purposes upon submission of formal data request, including a research proposal and data analysis plan. Requesters must sign a data-sharing agreement ensuring confidentiality, proper data use, and acknowledgement of the original study.
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 11/08/2025 PACTR Admin Preschool Child: 2 Year-5 Year Preschool Child: 2 Year-5 Year, Child: 6 Year-12 Year