Iron Babies Pilot Supplementation Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anaemia in Early Infancy
- Iron Deficiency
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Daily iron (1.5mg/kg/day as ferrous sulphate) or placebo drops starting from six weeks of age for 98 days. Please note that the daily iron supplement is the intervention product/drugMasking: Double (Care Provider, Investigator)Masking Description: This will be a two-arm, randomised, placebo-controlled double-blind study. Children will be randomised (1:1) to iron drops or placebo arm.Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 610 years
- Gender
- Both males and females
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...
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
Tracking Information
- NCT #
- NCT04751994
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Carla Cerami, MD, PhD Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine
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