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Malaria and Iron deficiency study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR2010050002141682
Enrollment
600
Registered
2010-05-28
Start date
2010-06-04
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haematological Disorders Malaria Paediatrics

Interventions

Placebo and Ferric Ammonium Citrate
Ferric Ammonium Citrate and Placebo
Placebo

Sponsors

College of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Proportion of children without anaemia (Hb >10.9g/dl);Incidence of bacterial infections and clinical malaria re-infections

Secondary

MeasureTime frame
Incidence of all-cause sick clinic visits;Incidence of all-cause hospital admissions;Incidence of infective-cause hospital admissions;Change in iron status markers (ZPP, MCV, sTfR, ferritin)

Countries

Malawi

Contacts

Public ContactExnevia Gomo

Director of Research Support Centre

egomo@rsc.medcol.mw+2651871911

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026