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.: PACTR201906819960554 Date of Registration: 27/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of a strategy combining the promotion of responsive feeding with the daily consumption of a fortified cereal-based blend to reduce anemia, micronutrient deficiencies and stunting in infants from Amparafaravola District, Madagascar
Official scientific title Efficacy of a strategy combining the promotion of responsive feeding with the daily consumption of a fortified cereal-based blend to reduce anemia, micronutrient deficiencies and stunting in infants from Amparafaravola District, Madagascar
Brief summary describing the background and objectives of the trial In Madagascar, stunting and anemia affected respectively 47% (2012) and 50% (2008) of children under 5 years and remain of public health concern. In this context, the traditional complementary foods given to children do not cover their daily needs. Infants and young children often exhibit a small appetite that does not allow them to ingest enough nutrients from the complementary foods to adequately complement the nutrient intakes from breast milk. The practice of responsive feeding is recommended by WHO since 2001 to encourage children to eat, but there is little quantitative evidence to show the effect of applying this practice on nutritional intakes or nutritional status of children. Consumption of a fortified food of adequate energy and nutritional quality associated to the promotion of responsive feeding in order to encourage children to eat could increase their intakes and consequently prevent different forms of malnutrition including iron deficiency anemia and stunting. This trial will compare four arms
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PFOA Efficacy
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 18/03/2019
Actual trial start date
Anticipated date of last follow up 18/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 800
Actual target sample size (number of participants)
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling 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 Fortified Complementary Food one time per day, depending on age 9 months Wash Intervention (see control group for details) + Provision of a vitamin and mineral fortified complementary food for infants from 6 months of age onwards 200 Uncontrolled
Experimental Group Responsive feeding daily 9 months Wash Intervention (see control group for details) : + Behavioural training of mothers to responsive feeding 200
Experimental Group Fortified complementary food plus responsive feeding daily 9 months Wash intervention (see control group) + combination of fortified complementary food and promotion of responsive feeding 200
Control Group control none 9 months WASH intervention: mother's participants receive soap, a water treatment product and an insecticide treated net. and they are sensibilized to key messages of water sanitation and hygiene 200 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Infant between 6 and 7 months of age - chronic disease requiring medical treatment - Genetic disorders affecting growth of the child Infant: 0 Month(s)-12 Month(s) 6 Month(s) 7 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
Yes 10/09/2018 Comite de ethique Ministere de la Sante Publique
Ethics Committee Address
Street address City Postal code Country
8, Rue KARIJA TSARALALANA ANTANANARIVA 8145 Madagascar
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome increments in length expressed in cm and in HAZ-scores 0, 3, 6 and 9 months
Primary Outcome Iron status as measured by serum ferritin and sTfR concentrations 0 and 9 months
Primary Outcome vitamin A status as measured by RBP concentrations 0 and 9 months
Primary Outcome thiamine status 0 and 9 months
Primary Outcome amount of fortified complementary food consumed 0, 3, 6 and 9 months
Secondary Outcome cognitive development of the infants 0 and 9 months
Secondary Outcome morbidity of the infants during the trial every month
Secondary Outcome intestinal parasite prevalence 0 and 9 months
Secondary Outcome weight gain expressed in kg and WAZ scores and Weight-for-height z-scores 0, 3, 6 and 9 months
Secondary Outcome infant feeding practices 0, 3, 6, and 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Health Centres around Amparafaravola no address Amparafaravola Madagascar
FUNDING SOURCES
Name of source Street address City Postal code Country
European Union 43 rue de la Loi Brussels 1040 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Europeaid 43 rue de la Loi Brussels Belgium Funding Agency
COLLABORATORS
Name Street address City Postal code Country
GRET representation de Madagascar Ambatomainty Antananarivo Madagascar
French National Research Institute for Sustainable Development IRD 911 Av. d.Agropolis Montpellier France
University of Antananarivo Ambohitsaina Antananarivo Madagascar
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Claire Mouquet claire.mouquet@ird.fr +33467416295 911 Av d.Agropolis
City Postal code Country Position/Affiliation
Montpellier France Senior Researcher
Role Name Email Phone Street address
Principal Investigator Yannick Razafindratsima razafindratsima.mg@gret.org +261340815130 Lot II A 119 S, Soavimbahoaka
City Postal code Country Position/Affiliation
Antananarivo Madagascar Researcher
Role Name Email Phone Street address
Public Enquiries Frank Wieringa franck.wieringa@ird.fr +33679580912 911 Av. d.Agropolis
City Postal code Country Position/Affiliation
Montpellier France Senior Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We are planning to publish the study protocol in an open-access journal soon. Study Protocol 2 years after completion of data collection open access, hence no limitation to access
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