Iron Babies Pilot Supplementation Trial

NCT04751994 | Completed Phase 3 DMC

• 1 other identifier: LEO 19092
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Iron-deficiency; Anaemia in Early Infancy

Keywords

anaemia, infant

Outcome Measures

Primary Outcomes (1)

• serum iron level

  Serum iron concentration at days 0 and 99

  at day 0 and at day 99

Secondary Outcomes (13)

• Haemoglobin concentration

  at day 0 and at day 99

• Percentage of infants with anaemia

  at day 99

• breast feeding

  weekly up to week 14

• maternal reported illnesses

  daily up to day 99

• adverse events assessment

  daily up to day 99

Study Arms (2)

Iron supplement/ ferrous sulphate syrup

EXPERIMENTAL

administration of daily iron drops, 7.5mg/day iron as ferrous sulphate

Dietary Supplement: Iron drops/Ferrous sulphate

supplement with placebo

PLACEBO COMPARATOR

administration of daily placebo drops

Dietary Supplement: Placebo drops

Interventions

Iron drops/Ferrous sulphate DIETARY_SUPPLEMENT

participant will consume daily drops of iron

Also known as: Ferrous Sulphate syrup

Iron supplement/ ferrous sulphate syrup

Placebo drops DIETARY_SUPPLEMENT

Participants will consume daily drops of placebo

Also known as: Sorbitol Solution 70%

supplement with placebo

Eligibility Criteria

• Age: 6 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

Keneba Field Station

Keneba, The Gambia

Location

Related Publications (1)

• Stelle I, Bah M, Silverio SA, Verhoef H, Comma E, Prentice AM, Moore SE, Cerami C. Iron supplementation of breastfed Gambian infants from 6 weeks to 6 months of age: protocol for a randomised controlled trial. Wellcome Open Res. 2022 Jan 18;7:16. doi: 10.12688/wellcomeopenres.17507.1. eCollection 2022.

  PMID: 36874582 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Carla Cerami, MD, PhD

  Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a two-arm, randomised, placebo-controlled double-blind study. Children will be randomised (1:1) to iron drops or placebo arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Daily iron (7.5mg/day as ferrous sulphate) or placebo drops starting from six to ten weeks of age for 98 days. Please note that the daily iron supplement is the intervention product/drug

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 12, 2021
• Study Start: August 3, 2021
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)