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.: PACTR202107669905145 Date of Approval: 13/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Moringa Oleifera Consumption on Protein and Vitamin A Status of Children with Cerebral Palsy in Nairobi, Kenya: A Randomized Controlled Trials
Official scientific title Effect of Moringa Oleifera Consumption on Protein and Vitamin A Status of Children with Cerebral Palsy in Nairobi, Kenya: A Randomized Controlled Trials
Brief summary describing the background and objectives of the trial Malnutrition, secondary to feeding dysfunctions is common in children suffering from Cerebral Palsy (CP) and is related to inadequate protein intake which is consequently associated with vitamin A deficiency. A diet that is both nutrient-dense and easy to chew and swallow is necessary to improve the protein and vitamin A status of these children. Previous studies have reported the potential of Moringa oleifera leaf powder in alleviating nutritional deficiencies. The purpose of this study was to test the effect of M. oleifera consumption on the protein and vitamin A status of children with CP. Phase one involved the development, nutrient analysis and sensory evaluation of a fermented finger millet porridge fortified with M. oleifera leaf powder for the intervention. The second phase was a randomized clinical controlled trial with a sample of 113 children with CP randomly allocated to 2 study groups (intervention and control) on a 1:1 ratio.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cerebral Palsy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Nutrition intervention
Anticipated trial start date 07/05/2018
Actual trial start date 07/05/2018
Anticipated date of last follow up 03/08/2018
Actual Last follow-up date 03/08/2018
Anticipated target sample size (number of participants) 114
Actual target sample size (number of participants) 113
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group moringa oleifera fortified finger millet porridge Given a 250 ml cup of unfortified fermented finger millet porridge daily five days a week for three months Three months Given a 250 ml cup of unfortified fermented finger millet porridge daily five days a week for three months No sharing of cups or porridge. Left-over porridge for each serving was measured and discarded to avoid cross contamination 57 Active-Treatment of Control Group
Experimental Group moringa oleifera fortified finger millet porridge Given a 250 ml cup of fortified fermented finger millet porridge daily five days a week for three months Three months Given a 250 ml cup of fortified fermented finger millet porridge daily five days a week for three months No sharing of cups or porridge. Left-over porridge for each serving was measured and discarded to avoid cross contamination 57
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criterion was children 5-11 years of age attending Little Rock Day Care Centre and diagnosed by a medical doctor to have CP. Children with CP with chronic ailments such as; cardiovascular diseases, cancer, renal dysfunction and liver problems diagnosed by a medical doctor were excluded since these would independently affect food intake. Additionally, those whose caregivers declined to participate or give consent were also excluded from the study. Child: 6 Year-12 Year 5 Year(s) 11 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 27/09/2017 KENYATTA UNIVERSITY ETHICS REVIEW COMMITTEE
Ethics Committee Address
Street address City Postal code Country
KENYATTA UNIERSITY, NAIROBI Nairobi 43844-001 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcomes: • Protein status determined by serum albumin • Vitamin A status determined by serum retinol level • Dietary intake determined by types and amounts foods eaten Baseline and end line
Secondary Outcome Wasting/weight gain determined by BMI – for-age Z-scores Morbidity prevalence determined by the frequency and type of illness Based on a two week recall Socio-demographic and economic characteristics of caregivers determined by Age, sex of the participant, Education level, occupation and income of the parents baseline and end line
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LITTLE ROCK ECD CENTER KIBRA NAIROBI 00505 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
NATIONAL RESEARCH FUND NRF KENYA UTALII HOUSE,9TH FLOOR NAIROBI 26036-001 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NATIONAL RESEARCH FUND NRF KENYA UTALII HSE 9TH FLOOR NAIROBI 26036-001 Kenya Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator JANET MALLA janetmalla@yahoo.com +254720813556 Mbagathi Road
City Postal code Country Position/Affiliation
NAIROBI 2871-0020 Kenya Principal investigator
Role Name Email Phone Street address
Scientific Enquiries SOPHIE OCHOLA ocholasa55@gmail.com +254721449803 nairobi
City Postal code Country Position/Affiliation
NAIROBI 43844-001 Kenya PRINCIPAL SUPERVISOR
Role Name Email Phone Street address
Public Enquiries ANN MUNYAKA munyaka.ann@ku.ac.ke +254712108087 nairobi
City Postal code Country Position/Affiliation
NAIROBI 43844-001 Kenya THIRD SUPERVISOR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol available Beginning 9 months and ending 36 months following article publication Study Protocol 2Years Open
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