Benefits and safety of IRon supplementation with MAlaria chemoprevention to children in Malawi (IRMA) - A randomised controlled trial

Phase 3

Active, not recruiting

• Conditions: Anaemia; Malaria; Impaired child cognitive development; Stunting; Diarrhoea; Iron Deficiency; Blood - Anaemia; Infection - Other infectious diseases; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12620000386932
• Lead Sponsor: College of Medicine, University of Malawi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-20
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 2168

Inclusion Criteria

1.Infants aged 6 months (+/- 14 days) at the time of randomisation
2.Has a legally acceptable guardian/representative capable of understanding the informed consent document and providing consent on the participant’s behalf

Exclusion Criteria

1.Severe anaemia (Hb<7g/dL) or
2.Current infective illness with fever (respiratory infection, diarrhoea, malaria); however, children will be screened again after recovery and recruited as long as they meet the age eligibility criteria at second screening
3.Severe malnutrition (weight-for-length z-score<-3);
4.Established diagnosis of haemoglobinopathy (e.g. sickle cell disease, beta thalassaemia major, HbE-beta thalassaemia).
5.Legal guardian unwilling or unable to provide written informed consent
6.Known congenital anomaly, developmental disorder or severe developmental delay
7.Children with physical or behavioural problems that will make it impossible to test the child
8.Children of multiple birth e.g. twin, triplets etc.
9.Currently consuming MNPs e.g. from the National MNP programme

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive development: assessed by the Bayley® 3rd Edition (Bayley-III) Cognitive Composite Score (CogCS)[End Intervention period (6 months post recruitment)]