Iron Babies Pilot Supplementation Trial

Phase 1

• Conditions: Nutritional, Metabolic, Endocrine; Paediatrics

• Registration Number: PACTR202102892966266
• Lead Sponsor: Medical Research Council at London School of Hygiene and Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Infants (male or female) at 6 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 Criteria

• Low birthweight babies (i.e. less than 2.5kg at birth) or babies born prematurely (i.e. 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-Barre´ 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum iron after 98 days of iron supplementation. Serum iron will be measured in venous blood collected at trial enrolment and 14 weeks after initiation of iron supplementation.

Secondary Outcome Measures

Name	Time	Method
The proportion of babies with anaemia (Hb <11 g/dL) and proportion of iron deficiency (sTfR/logFerritin ratio <2.0 hepcidin < 5.5 ng/L) at day 98.<br>