Benefits and Risks of Iron interventionS in Children (BRISC): a randomized controlled trial in Bangladesh

Phase 3

Completed

• Conditions: Anaemia; Iron Deficiency; Undernutrition; Diarrhoea; Blood - Anaemia; Diet and Nutrition - Other diet and nutrition disorders; Neurological - Studies of the normal brain and nervous system

• Registration Number: ACTRN12617000660381
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-08
• Study Completion: 2020-02-10
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3300

Inclusion Criteria

Each participant must meet all of the following criteria to be enrolled in this study:
-Is aged 8 months (+/-14 days) at the time of randomisation
-Is not expected to leave the study site (leave local village or the Rupganj area) for more than 1 week over the next 3 months, or for more than one month over the next 12 months.
-Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf.

Exclusion Criteria

Children meeting any of the following criteria will be excluded from the study:
- Has a capillary Hb at screening of <8.0g/dL at the time of screening
- Drinking water iron level >1gm/L
- Has an established diagnosis of any homozygous or compound heterozygous haemoglobinopathies (i.e. beta thalassaemia major, HbE-beta thalassaemia).
- Current infective illness with fever (respiratory infection, diarrhoea); however, children will be screened again after recovery and recruited as long as the meet the age eligibility criteria at second screening.
- Legal guardian unwilling or unable to provide written informed consent.
- Has not received iron supplements or iron-containing multiple micronutrient powders in the previous month. Families who self-procure iron/MMP during or after the intervention period will not be dropped from the study, but we will record the dose and duration and continue monitoring
- Known congental anomaly, developmental disorder or severe developmental delay
- It is not possible to test the child due to physical or behavioural problems
- Children of multiple birth e.g. twin, triplets

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive development assessed by the Bayley III Cognitive Composite Score[End of intervention (3 months)]