Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751994
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2021-01-27
Brief Title:
Iron Babies Pilot Supplementation Trial
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Enhancing Brain Development by Early Iron Supplementation of African Infants An Enabling Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Iron Babies
Brief Summary:
2-arm double blind placebo controlled randomised trial with 50 6-week-old infants per arm randomized to 98 days of daily iron 15mgkgday 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 ironplacebo supplementation
Participants will be visited daily in their villages by Fieldworkers FW to administer the ironplacebo dose and will interview mothers to complete a short health questionnaire The iron will be dosed at 75 of WHO guideline dose ie 15mgkgday 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 motherguardian reports that the child is unwell the study nurse will check on the child and decide on treatmentreferral to the nearest health centre
Participants will be visited daily in their villages by Fieldworkers FW to administer the ironplacebo dose and will interview mothers to complete a short health questionnaire The iron will be dosed at 75 of WHO guideline dose ie 15mgkgday 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 motherguardian reports that the child is unwell the study nurse will check on the child and decide on treatmentreferral to the nearest health centre
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None