Iron Babies Pilot Supplementation Trial (Iron Babies)

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

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

Study Overview

• Status: Completed
• Conditions: Iron-deficiency; Anaemia in Early Infancy
• Intervention / Treatment: Dietary supplement: Iron drops/Ferrous sulphate; Dietary supplement: 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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Gambia
  • Keneba, Gambia
    • Keneba Field Station

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron supplement/ ferrous sulphate syrup; administration of daily iron drops, 7.5mg/day iron as ferrous sulphate	Dietary supplement: Iron drops/Ferrous sulphate; participant will consume daily drops of iron; Other Names: Ferrous Sulphate syrup
Placebo Comparator: supplement with placebo; administration of daily placebo drops	Dietary supplement: Placebo drops; Participants will consume daily drops of placebo; Other Names: Sorbitol Solution 70%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum iron level	Serum iron concentration at days 0 and 99	at day 0 and at day 99

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin concentration	Haemoglobin concentration at days 0 and 99	at day 0 and at day 99
Percentage of infants with anaemia	Percentage of infants with anaemia (defined as: Hb< 110g/L, )	at day 99
breast feeding	Duration of breast feeding assessed weekly, up to study day 98.	weekly up to week 14
maternal reported illnesses	Proportion of maternal-reported illnesses assessed daily up to study day 99.	daily up to day 99
adverse events assessment	Proportion of adverse events assessed daily, up to study day 99	daily up to day 99
Serious adverse events (SAE) assessment	Proportion of serious adverse events assessed daily, up to study day 99	daily up to day 99
raised inflammatory markers assessment	Proportion of raised inflammatory markers (CRP/AGP)	after 98 days of supplementation
iron deficiency anemia (Hb < 11 g/dL & sTfR/logFerritin ratio < 2.0 and ferritin < 12 ug/L or < 30 ug/L in the presence of inflammation	Proportion of children that are iron deficiency anaemia (Hb < 11 g/dL & sTfR/logFerritin ratio < 2.0 and ferritin < 12 ug/L or < 30 ug/L in the presence of inflammation)	at day 0 and day 99
Fecal iron after supplementation	Fecal iron assessed at day 0 and day 99	day 0 and day 99
Iron regulation	Hepcidin levels at day 0 and day 99	day 0 and day 99
Reticulocytes at day 0 and day 99	Reticulocytes at day 0 and day 99	day 0 and day 99
Erythropoietin at days 0 and 99	Erythropoietin at days 0 and 99	day 0 and 99
Erythroferrone at days 0 and 99	Erythroferrone at days 0 and 99	day 0 and 99

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Investigators: Principal Investigator: Carla Cerami, MD, PhD, Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Actual): March 9, 2022
• Study Completion (Actual): March 9, 2022

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: anaemia, infant
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Gastrointestinal Agents; Cathartics; Sorbitol
• Other Study ID Numbers: LEO 19092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be kept anonymous. There are currently no plans to share individual patient data beyond the investigator team. However, following all requisite approvals, an anonymized copy of the data can be made available for sharing. All key findings from this study will be submitted for publication in peer-reviewed journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes