Status:
COMPLETED
Iron Babies Pilot Supplementation Trial
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Conditions:
Iron-deficiency
Anaemia in Early Infancy
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
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 (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 affe...
Eligibility Criteria
Inclusion
- Infants (male or female) from 6 weeks to 10 weeks of age.
- Breast fed infants (with plans to continue breastfeeding through 6 months of age).
- Parent/guardian with participant reside in study site area and are able and willing to adhere to all protocol visits and procedures (willingness to stay in the study area for the 14 weeks of supplementation).
- Healthy with no current illness and no chronic health problems.
- Signed or fingerprinted informed consent obtained from participants parent/guardian
Exclusion
- Low birthweight babies (ie less than 2.5kg at birth) or babies born prematurely (ie less than 37 weeks) will NOT be excluded.
- Formula fed infants or those planning to terminate exclusive breast feeding before 6months of age.
- Acute illness (once acute illness is resolved, if appropriate, as per investigator assessment, participant may be re-revaluated for eligibility)
- Fever (for eligibility purpose defined as a body temperature greater than 37.5°C or mother report of fever) within 3 days prior to study initiation (once fever/acute illness is resolved, if appropriate, as per investigator assessment, participant may be re-revaluated for eligibility).
- Administration of any investigational drug within 30 days prior to study initiation or planned administration during the study period.
- Unwilling to avoid (their child to avoid) the ingestion of supplements or herbal/other traditional medications during the study period.
- Any history of or evidence for chronic clinically significant (as per investigator assessment) disorder or disease (including, but not limited to, immunodeficiency, autoimmunity, congenital abnormality, bleeding disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease).
- Any history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections.
- History of meningitis, seizures, Guillain-Barré syndrome, or other neurological disorders.
- Any condition that in the opinion of the investigator might compromise the safety or well- being of the participant or compromise adherence to protocol procedures
Key Trial Info
Start Date :
August 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04751994
Start Date
August 3 2021
End Date
March 9 2022
Last Update
May 26 2022
Active Locations (1)
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1
Keneba Field Station
Keneba, The Gambia