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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR2010050002141682 |
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Date of registration:
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28/05/2010 |
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Primary sponsor: |
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Public title:
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Malaria and Iron deficiency study
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Scientific title:
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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 |
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Date of first enrolment:
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2010-06-04 |
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Target sample size:
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600 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2010050002141682 |
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Study type:
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interventional |
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Study design:
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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,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Exnevia
Gomo |
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Address:
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P/Bag 360
Blantyre
Malawi |
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Telephone:
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+2651871911 |
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Email:
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egomo@rsc.medcol.mw |
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Affiliation:
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Director of Research Support Centre |
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Name:
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Kamija
Phiri |
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Address:
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P/Bag 360
Blantyre
Malawi |
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Telephone:
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+2651871911 |
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Email:
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kamijaphiri@gmail.com |
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Affiliation:
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Senior Lecturer |
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Key inclusion & exclusion criteria
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Inclusion criteria: ? 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
Exclusion criteria: ? 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
Age minimum:
4 Month
Age maximum:
24 Month
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria
null
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Primary Outcome(s)
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Incidence of bacterial infections and clinical malaria re-infections
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Proportion of children without anaemia (Hb b10.9g/dl)
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Secondary Outcome(s)
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Change in iron status markers (ZPP, MCV, sTfR, ferritin)
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Incidence of all-cause hospital admissions
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Incidence of all-cause sick clinic visits
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Incidence of infective-cause hospital admissions
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Source(s) of Monetary Support
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European & Developing Countries Clinical Trials Partnership
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