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.: PACTR2010050002141682 Date of Approval: 28/05/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Malaria and Iron deficiency study
Official scientific title A randomised placebo controlled trial of oral iron therapy for treatment of post-malaria anaemia in Malawian children comparing immediate post-discharge or delayed treatment on haematological response and iron uptake
Brief summary describing the background and objectives of the trial Recent studies in malaria endemic areas have shown adverse events to be associated with iron supplementation. The utility of oral compared to sequestered iron in the first two weeks after a malaria episode remains questionable and in anaemic children with malaria clear guidelines are not available on the optimal timing of use of oral iron. Objective is to determine the beneficial effects and adverse effects of immediate or two weeks delayed timing of oral iron therapy post-malaria anaemia
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MALARID
Disease(s) or condition(s) being studied Haematological Disorders,Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/06/2010
Actual trial start date
Anticipated date of last follow up 31/03/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Placebo and Ferric Ammonium Citrate 0.15ml/kg/day (placebo) and 3mg/kg/day (iron) 2 weeks placebo starting on randomisation followed by 8 weeks iron Delayed iron supplementation 200
Experimental Group Ferric Ammonium Citrate and Placebo 3mg/kg/day (iron) and 0.15ml/kg/day (placebo) 8 weeks iron starting on randomisation followed by 2 weeks placebo immediate iron supplementation 200
Control Group Placebo 0.15ml/kg/day 10 weeks Placebo 200 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Age between 4 and 24 months ¿ Have moderate anaemia (Hb 7.0-10.0 g/dL or PCV 21 ¿ 30%) ¿ Have documented uncomplicated malaria and have completed treatment with Lumefantrine artemether (LA) ¿ HIV seronegative ¿ Be resident in the study catchment area ¿ Have no known adverse reactions to oral iron ¿ Weigh 5 kg or more ¿ Had not used the study medication in the month preceding enrolment ¿ Have written informed consent from a parent / guardian to participate in the study ¿ severe malnutrition (weight-for-height <75% of expected, the presence of bi-pedal oedema) ¿ severe anaemia (Hb <7.0 g/dl or PCV <21%) ¿ persistent diarrhea ¿ Severe concomitant disease process 4 Month(s) 24 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 28/04/2010 College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P/Bag 360 Blantyre Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of children without anaemia (Hb >10.9g/dl) at the end of the iron supplementation period
Primary Outcome Incidence of bacterial infections and clinical malaria re-infections at the end of the iron supplementation period
Secondary Outcome Incidence of all-cause sick clinic visits by end of iron supplementation period
Secondary Outcome Incidence of all-cause hospital admissions by end of iron supplementation period
Secondary Outcome Incidence of infective-cause hospital admissions by end of iron supplementation period
Secondary Outcome Change in iron status markers (ZPP, MCV, sTfR, ferritin) at begining of iron supplementation at end of iron supplementation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ndirande Health Centre Blantyre Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
European & Developing Countries Clinical Trials Partnership 334 Laan van Nieuw Oost Indië The Hague 2509 AA Netherlands
European & Developing Countries Clinical Trials Partnership 334 Laan van Nieuw Oost Indië The Hague 2509 AA Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor College of Medicine Mahatma Ghandi Road, P/Bag 360 Blantyre Malawi University
Primary Sponsor College of Medicine Mahatma Ghandi Road, P/Bag 360 Blantyre Malawi University
COLLABORATORS
Name Street address City Postal code Country
Prof Bernard Brabin Pembroke Plcae Liverpool L3 5QA United Kingdom
Prof Bernard Brabin Pembroke Plcae Liverpool L3 5QA United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kamija Phiri kamijaphiri@gmail.com +2651871911 P/Bag 360
City Postal code Country Position/Affiliation
Blantyre Malawi senior Lecturer
Role Name Email Phone Street address
Public Enquiries Exnevia Gomo egomo@rsc.medcol.mw +2651871911 P/Bag 360
City Postal code Country Position/Affiliation
Blantyre Malawi Director of Research Support Centre
Role Name Email Phone Street address
Scientific Enquiries Kamija Phiri kamijaphiri@gmail.com +2651871911 P/Bag 360
City Postal code Country Position/Affiliation
Blantyre Malawi Senior Lecturer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information