NCT04751994

Iron Babies Pilot Supplementation Trial

Enhancing Brain Development by Early Iron Supplementation of African Infants: An Enabling Pilot Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: 6 Weeks – 10 Weeks
• Healthy volunteers: Accepted

Summary

2-arm, double blind, placebo controlled, randomised trial, with 50 6-week-old infants per arm randomized to 98 days of daily iron (1.5mg/kg/day as ferrous sulphate) or placebo drops

Detailed description

Healthy infants will be randomised to receive daily supplementation from 6-20wks of either a) iron drops or b) placebo drops. Infants with significant illness or any clinical syndromes that would affect interpretation will be excluded. Low birthweight infants and infants born prematurely will not be excluded. Venous blood samples will be collected at enrollment (age 6 weeks) and after 14 weeks (98 days) of iron/placebo supplementation. Participants will be visited daily in their villages by Fieldworkers (FW) to administer the iron/placebo dose and will interview mothers to complete a short health questionnaire. The iron will be dosed at 75% of WHO guideline dose (ie 1.5mg/kg/day). Weekly, a more detailed morbidity and breastfeeding questionnaires will be administered. Infants will be weighed and measured monthly, along with a faecal sample being taken. During the daily visits, the FWs will record any adverse events (AEs) and ensure the safety of participants. If a child is found unwell or if the mother/guardian reports that the child is unwell, the study nurse will check on the child and decide on treatment/referral to the nearest health centre

Conditions

• Iron-deficiency
• Anaemia in Early Infancy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Iron drops/Ferrous sulphate	participant will consume daily drops of iron
DIETARY_SUPPLEMENT	Placebo drops	Participants will consume daily drops of placebo

Timeline

• Start date: 2021-08-03
• Primary completion: 2022-03-09
• Completion: 2022-03-09
• First posted: 2021-02-12
• Last updated: 2022-05-26

Locations

1 site across 1 country: The Gambia