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.: PACTR202109789766287 Date of Approval: 03/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Egg Supplementation on Nutritional Status, Physical Fitness and Cognition of School-aged Children (8-12 Years) in Ho Municipality, Ghana
Official scientific title Nutritional Status, Physical Fitness and Cognition and a household survey among of School-aged Children.
Brief summary describing the background and objectives of the trial children's daily nutritional needs Egg is a cheap source of essential micronutrients and high-quality protein, contributing to children's daily nutritional needs, supporting childhood growth and development, and brain development. Some studies in infants and children have demonstrated several significant associations with the consumption of eggs and other dietary interventions. A study by Papanikolaou and Fulgoni (2018), which used infants aged 6-24 months, found that introducing eggs to children’s diet was associated with improved nutrients profile including higher daily protein, docosahexaenoic acid (DHA), choline, vitamin B12, and alpha-linolenic acid, and was associated with a longer recumbent height of the study participants. Another study by Kucab et al. (2019) evaluated the effects of eggs and egg components on cognitive performance in children aged 9–14 Years. Kucab et al. found that children who consumed egg yolk had higher short-term learning and memory scores and cognitive processing test scores than those who consumed egg whites. In Kenya, a study by Whaley et al. (2003) assessed the impact of dietary intervention on the cognition performance of school children. Aim: The study will evaluate the effectiveness of Egg supplementation on nutritional status, physical fitness, and cognition of school-aged Children (8-12 Years) in Ho Municipality, Ghana. Specifically, the study sought to: 1. Determine dietary patterns and nutrient intake levels among school-aged children 2. Determine (stunting, underweight and wasting) status of the school-aged children anthropometrically 3. Assess the relationship between nutrient intake, anthropometric status and cognition scores
Type of trial CCT
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 Treatment: Other
Anticipated trial start date 01/08/2018
Actual trial start date 01/10/2018
Anticipated date of last follow up 01/02/2019
Actual Last follow-up date 30/03/2019
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 195
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group No treatment was given to this group. Three months No intervention was provided to the control group. 115 Uncontrolled
Experimental Group experiment group three (3) eggs per week Three months The intervention group was given three (3) eggs per week for three months. The Eggs were served hard-boiled and consumed as a snack during the school days. 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy-looking school-age children who voluntarily accepted to participate with parental consent were included in the study. Children with any physical disability or above 13 and below 8 years old were excluded from the study. Pupils who parent did not consent were also excluded. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 8 Year(s) 13 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 04/05/2018 COMMITEE ON HUMAN RESEARCH PUBLICATION AND ETHICS
Ethics Committee Address
Street address City Postal code Country
KNUST Kumasi ROOM7 BJ Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome serum ferritin serum zinc serum albumin BASELINE AND ENDLINE
Secondary Outcome COGNITION, FITNESS and BMI FOR AGE BASELINE AND ENDLINE
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
SCHOOL HOUSING BASIC SCHOOL AND MAWULI BASIC SCHOOL A HO HO/HO Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PRISCILLA CECILIA AKPENE AMENYA TRFALGA HO BOX 34 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator PRISCILLA CECILIA AKPENE AMENYA priscillaamenya@yahoo.co.uk 0233243621875 TRAFLAGA
City Postal code Country Position/Affiliation
HO BOX 34 Ghana LECTURER AT UNIVERSITY OF HEALTH AND ALLIED SCIENCES
Role Name Email Phone Street address
Public Enquiries Reginald Annan reggie@imtf.org 0233201237169 KNUST
City Postal code Country Position/Affiliation
KUMASI KNUST Ghana SENIOR LECTURER AT KWAME NUKRUMAH UNIVERSITY OF SCIENCE AND TECHNOLOGY
Role Name Email Phone Street address
Scientific Enquiries Charles Apprey appreycharles@gmail.com 0233243826275 KNUST
City Postal code Country Position/Affiliation
KUMASI KNUST Ghana LECTURER ATKWAME NUKRUMAH UNIVERSITY OF SCIENCE AND TECHNOLOGY
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes DATA FOR THIS RESEARCH WORL CAN BE ASSESSED BY WRITING TO THE CHAIR, COMMITTEE ON HUMAN RESEARCH, PUBLICATION AND ETHICS, Room 7 Block J, School of Medical Sciences, KNUST, University Post Office, Kumasi, Ghana Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 MONTHS PRINCIPAL, INVESTIGATOR, SUPPERVORS AND ETHICS COMMITTEES
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 01/09/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/09/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information