Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201802003069111 Date of Registration: 09/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of an iron fortified wheat flour for the correction and the prevention of iron deficiency anaemia of children in Salapoumbe
Official scientific title Efficacy of an iron fortified wheat flour for the correction and the prevention of iron deficiency anaemia in 18 to 59 months old children in Salapoumbe (East-Cameroon).
Brief summary describing the background and objectives of the trial Background:Iron fortification of food for the fight against iron deficiency anaemia effectiveness is not shown in many Sub-Saharan African countries. Objective: To evaluate the efficacy of iron fortified wheat flour for the correction and the prevention of iron deficiency anaemia among 18-59 months old children in Salapoumbé in Cameroon.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FARFER
Disease(s) or condition(s) being studied Haematological Disorders,iron deficiency aneamia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 20/02/2017
Actual trial start date 20/02/2017
Anticipated date of last follow up 21/08/2017
Actual Last follow-up date 21/08/2017
Anticipated target sample size (number of participants) 205
Actual target sample size (number of participants) 155
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 randomisation with coin -tossing 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 placebo 0 6 months supplemental feeding of usual diet with placebo wheat flour 99 Placebo
Experimental Group iron fortification 7.5 mg of furamate iron daily 6 months supplemental feeding of usual diet with iron fortified wheat flour 106 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Apparent good health - Age ranging 18 to 59 months; - Haemoglobin rate ranging 7 to 11 g/dl - Current iron supplementation; - Apparent signs of severe malnutrition; - An observed chronic pathology (tuberculosis, AIDS, cycle cell disease¿); - Severe acute infection (serious malaria, pneumonia, meningitis¿); - Blood transfusion of less than 3 months; - Allergy to the cow's milk and/or to the gluten 18 Month(s) 59 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 15/03/2016 NATIONAL ETHICAL COMMITTEE OF RESEARCH FOR HUMAN HEALTH
Ethics Committee Address
Street address City Postal code Country
Rue Manga-Bell, Messa Yaoundé Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Haemoglobin rate, serum ferritin, serum iron, transferrin saturation, anaemia rate, iron deficiency rate,iron deficiency rate, baseline, mid-point, End-point
Secondary Outcome weight, height baseline, midpoint, endpoint
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hôpital Catholique de Salapoumbe Route de Yokadouma Salapoumbe B.P 003 , Yokadouma Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
MINISTRY OF HEALTH AND PUBLIC ASSISTANCE RUE 3.081 Yaounde Cameroon
Nestlé Nutrition Institute of Africa 8 Anslow Crescent, Anslow Office Park Bryanston, South Africa, 2021 Bryanston 2021 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nestlé Nutrition Institute of Africa 8 Anslow Crescent, Anslow Office Park Bryanston, South Africa, 2021 Bryanston 2021 South Africa Charities/Societies/Foundation
Secondary Sponsor MINISTRY OF HEALTH AND PUBLIC ASSISTANCE RUE 3.081 Yaounde Cameroon Funding Agency
COLLABORATORS
Name Street address City Postal code Country
BIANPAMBE OUSMAILA IGNAGALI Rue Bounoung Mbono Yaoundé 2036 Cameroon
FELICITEE NGUEFACK Rue Bounoung Mbono Yaounde Cameroon
MARIE M KANA-SOP Carrefour Ange raphaël Douala Cameroon
MEDOUA GABRIEL Carrefour EMIA Yaounde Cameroon
KOKI NDOMBO PAUL Rue Henry Dunant, Messa Yaoundé Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator EKOE TETANYE tetanyeekoe@yahoo.fr +237 77 54 30 30 Rue Bounoung Mbono
City Postal code Country Position/Affiliation
Yaounde B.P 2036 Cameroon Emeritus Professor of paediatrics / Université of Yaounde I
Role Name Email Phone Street address
Public Enquiries Serge Dzeukou sergeberlin.dzeukou@cm.nestle.com +237 71 65 70 87 Rue Prince de Galles-AKWA
City Postal code Country Position/Affiliation
Douala Cameroon Regional officer of Nestlé Nutrition Institute for Central and West Africa
Role Name Email Phone Street address
Scientific Enquiries JEAN LOUIS ESSAME OYONO essame.oyono@gmail.com +237 677 70 88 88 Carrefour Emia
City Postal code Country Position/Affiliation
Yaounde Cameroon Emeritus professor of pathology/ general manager IMPM
REPORTING
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