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.: PACTR201906918438423 Date of Approval: 25/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Kumbungu Trial
Official scientific title Effects of Locally Available Dietary Intervention, in the community-based management of anaemia in children under five: Kumbungu Cluster Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: Anaemia in children under five years is an important public health problem requiring urgent attention. The global prevalence is worse in Africa and Asia. In Ghana seven out of ten children under five years are anaemic. Anaemia is associated with significant morbidity and mortality affecting physical and mental development of children. The aim of the study is to evaluate the safety and efficacy of Locally Available Dietary Intervention in combination with Iron Folic Acid in the community based management of anaemia in children under five years. Objectives 1. To determine the baseline prevalence of anaemia and iron deficiency anaemia among children under five years in the Kumbungu district. 2. To determine factors associated with anaemia among children under five years in the Kumbungu district of Ghana 3. To develop a Locally Available Dietary (LAD) intervention which is culturally acceptable, cost effective and nutritionally appropriate for a behavioural change communication 4. To test the effects of LAD intervention in children aged 6-59 months receiving iron and folic acid for anaemia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) KRCT
Disease(s) or condition(s) being studied Haematological Disorders,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 15/10/2020
Actual trial start date
Anticipated date of last follow up 15/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 184
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Locally available dietary intervention plus iron and folic acid Monthly locally available dietary intervention counseling administered to parents of children under 5 years receiving iron and folic acid for treatment of anemia. iron and folic acid would be taken daily according to WHO guideline for age of child 12 weeks Intervention pertains to both cluster and individual level. At the cluster level, randomised household would each received targeted LAD intervention aimed at promoting the intake of locally available iron, folate and vitamin B12 rich foods, food rich in enhancers of iron absorption and discouraging the intake of food rich in inhibitors of iron absorption. The rest of the interventions are targeted at the individual participant level. All study participants would receive the current practiced standard treatment for anaemia; iron + folic acid. The standard care arm would receive only the iron plus folic acid syrup. The standard plus arm (arm two) would receive iron, folic acid syrup treatment plus LAD intervention. All two arms of the study would run parallel and would be randomized in the ratio 1:1. The dosage of Iron and folic acid to be dispensed would be according to the current WHO recommended dose for age of the child [26]. Each study participant is required to take the prescribed doses daily. Monthly iron and folic acid requirement shall be dispensed to mothers/guardians. A member of the study team shall visit each household every week to monitor the administration of the iron and folic acid. Behavioural change communication administered at household level shall include a set of five points counselling guideline promoting the intake of food rich in enhancers of iron absorption and discouraging the intake of food poor in enhancers iron absorption. This guideline would be administered monthly to randomized households in a LAD arm. In all mothers/guardians of households randomized for LAD would receive three monthly BCC counselling. A monthly semi-quantitative assessment of intake of iron, folic acid and vitamin B12 intake as well as known inhibitors/enhancers of iron absorption of iron intake shall be determined at baseline (week 0), and then weeks 4, 8 and 12. 92
Control Group iron and folic acid only group Iron and folic acid administered according to the WHO guideline for age of child 12 weeks Iron + Folic Acid (IFA arm): Standard care arm The standard care arm would receive only the iron plus folic acid syrup. Each study participant is required to take the prescribed doses daily. Monthly iron and folic acid requirement shall be dispensed to mothers/guardians. A member of the study team shall visit each household every week to monitor the administration of the iron and folic acid. 92 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
At the cluster level, household inclusion to the study must satisfy the following: i. Household within the selected community. ii. The household must have at least a child aged 6 to 56 months. Inclusion criteria at the participant level; i. All children within the eligible household aged 6 to 56 months at baseline. ii. Haemoglobin concentration measured at baseline should be less than 11.0 g/dl. iii. The child should be residing in the selected community for at least the past three month. iv. Must have a legal guardian capable of providing informed consent. Eligible children with any of the following would be excluded from the study: i. Current infective illness (example; respiratory infection, diarrhoea) with fever; however, children may be rescreened again after recovery if otherwise eligible. Current infective illness would be assessed from self-reported and verification of available medical records. ii. Diagnosed case of any clinical haemoglobinopathy (eg, beta-thalassemia major, HbE-beta thalassemia, Sickle cell disease). This will be assessed based on self-report and available medical and laboratory records. iii. Received iron supplements or iron-containing MMP in the previous month. Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 56 Month(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 28/05/2019 Ghana Health Service ethical review board
Ethics Committee Address
Street address City Postal code Country
Accra Accra 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean haemoglobin levels and prevalence of anaemia in study arms Baseline week 0 and Endline week 12
Secondary Outcome Measurement of anthropometry, dietary recall, serum iron, ferritin, and other parameters of full blood count Baseline week 0 and Endline week 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Public Health department Tamale Teaching Hospital Hospital road Tamale 00233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Benjamin D Nuertey Community health department, Korle-Bu Accra Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ghana Michigan Collaborative research funding University of Michigan Medical School 1111 Catherine St., 221 Victor Vaughn Building Ann Arbor, MI 48109 Michigan United States of America Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Prof. Alfred E. Yawson Community Health department, School of public health, University of Ghana Accra Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Benjamin Nuertey ben.nuertey@gmail.com +233246968106 Community Health department, School of Public Health, University of Ghana,
City Postal code Country Position/Affiliation
Korle Bu campus Ghana Senior resident
Role Name Email Phone Street address
Public Enquiries Benjamin Nuertey ben.nuertey@gmail.com +233246968106 Community Health department, School of Public Health, University of Ghana,
City Postal code Country Position/Affiliation
Korle Bu campus Ghana Senior resident
Role Name Email Phone Street address
Scientific Enquiries Benjamin Nuertey ben.nuertey@gmail.com +233246968106 Community Health department, School of Public Health, University of Ghana,
City Postal code Country Position/Affiliation
Korle Bu campus Ghana Senior resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data would be made available to researchers upon reasonable request. All collected data without personal identifiers Study Protocol one year after the study Researchers in Africa
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