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.: PACTR202408897182810 Date of Approval: 08/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Egg-fortified Tom Brown Meal consumption on Haemoglobin and Iron level among School-aged Children in the Wa Municipality.
Official scientific title The trial is a study which seeks to assess the effects of Egg-fortified Tom Brown Meal consumption on Haemoglobin and Iron level among School-aged Children in the Wa Municipality. The meal will be provided for the study participants for 24 weeks and then its impact on the parameters will be assess by comparing measurements before and after the intervention. The study will have both intervention and control groups for comparison. The study is an RCT and the sample size is 68 pupils in each arm of the study.
Brief summary describing the background and objectives of the trial .Malnutrition, particularly anemia caused by iron deficiency, is a significant public health issue in developing regions such as the Wa Municipality of Ghana. Anemia can lead to severe health problems, including impaired cognitive development, decreased immunity, and reduced physical capacity, making it crucial to address this issue for improving children's overall health, educational performance, and future productivity (World Health Organization, 2015). Even though iron deficiency is not the only cause of anemia, iron is essential for the production of hemoglobin, which is responsible for transporting oxygen throughout the body. Inadequate iron intake leads to iron deficiency anemia, characterized by low hemoglobin levels (Akowuah et al., 2022). Foods rich in iron, particularly bioavailable sources like meat, poultry, and fish, are often scarce or unaffordable for many families in resource poor settings like the Wa Municipality, necessitating cost-effective and culturally acceptable ways to enhance iron intake. Eggs are highly nutritious, rich in proteins, vitamins, and minerals, including iron, and are relatively affordable and accessible (Campbell et al., 2018). They provide a bioavailable source of iron, better absorbed by the body compared to plant-based iron sources (Hurrell & Egli, 2010). Additionally, eggs contain other nutrients that support overall growth and development, making them an ideal food for improving children's nutritional status. Also, Tom Brown, a traditional Ghanaian porridge made from roasted maize or other grains, is commonly consumed as a breakfast food or weaning food for young children. While valued for its energy content, Tom Brown often lacks essential micronutrients (Nkegbe et al., 2013). Fortifying Tom Brown with nutrient-dense foods like eggs can enhance its nutritional value and address specific deficiencies prevalent among school-aged children in the region. Thus, fortifying Tom Brown with eggs presents a practical and sustainable intervention to improve hemoglobin and iron levels among school-aged children. This approach leverages locally available resources and traditional dietary practices to deliver enhanced nutrition. Previous studies have shown that food fortification strategies can effectively improve micronutrient status and overall health outcomes in children (Mannar & Gallego, 2020). The proposed intervention involves adding egg powder to the Tom Brown meal consumed by school-aged children, aiming to provide a more balanced and nutrient-rich diet. Thus, the working hypothesis of this study is that regular consumption of egg-fortified Tom Brown will lead to significant improvements in hemoglobin and serum iron levels among school-aged children in the Wa Municipality. Enhanced iron intake through the fortified meal could reduce the prevalence of iron deficiency anemia, contributing to better health, cognitive function, and academic performance (Allen et al., 2006). The working objectives of the study include to: 1. determine the nutritional composition and acceptability of egg powder-fortified Tom Brown among school aged children in wa Municipality 2. asses the predictors of anaemia and iron status among school age children in the Wa Municipality 3. assess the impact of egg powder–fortified Tom Brown meal consumption on haemoglobin Serum ferritin, C-reactive protein, IQ and academic performance among school aged children in the Wa Municipality
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IGA
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 01/05/2024
Actual trial start date 05/05/2024
Anticipated date of last follow up 01/11/2024
Actual Last follow-up date 05/11/2024
Anticipated target sample size (number of participants) 136
Actual target sample size (number of participants) 136
Recruitment status Active, not recruiting
Publication URL https://pactr.samrc.ac.za
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 by using procedures such as coin-tossing or dice-rolling 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 Egg powder fortified Tom brown meal consumption 250ml a day and 3 days in a week 24 weeks Feeding of egg powder fortified tom brown meal made from roasted yellow corn flour and prepared with some measured amount of sugar to enhance the taste to the intervention group (68 participants) The control group will also be fed with the standard tom brown without the egg powder for the same 24 weeks period (68 participants) 68
Control Group Non egg powder fortified Tom brown meal consumption 250ml a day and 3 days a week 24 weeks Tom brown prepared from roasted yellow corn flour with measured amount of sugar 68 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male and female school children aging between 5 to 12 years old with regular school attendance will be allowed to participate in the study. Participants older than 12 years and those less than 5 years will be excluded from the study. Pupils within the qualified age bracket with irregular school attendance shall be excluded from the study. Again, school children who are within the age group but do not show sign of anaemia or are not mildly anaemic will be excluded from the study. Child: 6 Year-12 Year 5 Year(s) 12 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
Yes 06/11/2023 KNUST
Ethics Committee Address
Street address City Postal code Country
College of Health Sciences SCHOOL OF MEDICINE AND DENTISTRY, Kwame Nkrumah University of Science and Technology, Kumasi Kumasi 0233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of the intervention is the effect it will have on the Hb levels of the study participants in the intervention group. Hb level of 11.5 or below before the intevention is described as Anemic, between 12.0 to 13.0 is described as at risk and Hb above 13 is considered normal in this study. The primary outcome is therefore to assess the impact of the breakfast meal on the Hb among the intervention group members. There will be two time points for outcome measurements. The pre-intervention outcome measurement was done in April 2024 and the post-intervention measurement will be done in November 2024
Secondary Outcome The secondary outcomes of the study are its impact on serum ferritin level of participants in the intervention group. The objective is to find out if the intervention is able to improve serum ferritin levels of study participants who have low serum ferritin levels before the intervention to normal levels of 15-150 ng/mL per their age 5-12 years. Pre-intervention measurement was done in April 2024 and post-intervention measurement will be done in November, 2024
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dr. Hilla Limann Technical University Kpogu road Wa 0233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Salary Kpogu road Wa 0233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nyefene Joe Dare Dr. Hilla Limann Technical University, P. O. Box 553, Wa Upper West Region, Ghana Wa 0233 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
Emmppek Foods Emmppek foods Ltd, Delta state, Nigeria Abraka 0533 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joe Dare Nyefene nyefenejoedare@gmail.com +233246417477 Kpogu road
City Postal code Country Position/Affiliation
Wa 0233 Ghana PhD student
Role Name Email Phone Street address
Scientific Enquiries Robertson Mills mirobfc2011@gmail.com +233246583884 Biochemistry and Biotechnology department, KNUST, Kumasi, Ghana
City Postal code Country Position/Affiliation
kumasi 0233 Ghana supervisor
Role Name Email Phone Street address
Public Enquiries Isaac Amoah isaacamoah458@gmail.com +233249183185 Nutrition and Dietetics department, KNUST
City Postal code Country Position/Affiliation
Kumasi 0233 Ghana supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD Sharing Statement: 1. Data Sharing Policy We are committed to promoting open science and the responsible sharing of data to advance research and knowledge. Individual participant data (IPD) collected during this study will be made available to researchers upon request, following the completion of the primary study objectives and publication of the main results. 2. What Data Will Be Shared: The following data will be shared: Individual-level data that underlie the results reported in the published articles, after de-identification (text, tables, figures, and appendices). Study protocol, Statistical Analysis Plan (SAP), and the Informed Consent Form (ICF). 3. When Will the Data Be Available Data will be available beginning 6 months after the publication of the primary study results and will be accessible for a period of 5 years. 4. How to Request Access to the Data Researchers can request access to the IPD by submitting a data access request form to the corresponding author. The request should include: A summary of the research proposal, including objectives, rationale, and the statistical analysis plan. Evidence of ethical approval for the secondary analysis from an accredited institutional review board (IRB) or ethics committee. 5. Conditions for Data Access Data will be shared with researchers who provide a methodologically sound proposal, as reviewed and approved by the study’s data access committee and Requestors will need to sign a data use agreement, which includes commitments to use the data only for the specified research purposes, to maintain data confidentiality, and to not attempt to re-identify participants. Data must be stored securely and access restricted to authorized personnel only. 6. Contact Information: Requests for access to the IPD should be directed to: Name: Joe Dare Nyefene Email: nyefenejoedare@gmail.com Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6-12 months after publication of the primary results Through research proposal and ethical approval
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://pactr.samrc.ac.za 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