Iron Babies Pilot Supplementation Trial

Sponsor
London School of Hygiene and Tropical Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT04751994
Collaborator
(none)
100
1
2
7.2
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Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Iron drops/Ferrous sulphate
  • Dietary Supplement: Placebo drops
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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/drugDaily 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
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
This will be a two-arm, randomised, placebo-controlled double-blind study. Children will be randomised (1:1) to iron drops or placebo arm.
Primary Purpose:
Prevention
Official Title:
Enhancing Brain Development by Early Iron Supplementation of African Infants: An Enabling Pilot Study
Actual Study Start Date :
Aug 3, 2021
Actual Primary Completion Date :
Mar 9, 2022
Actual Study Completion Date :
Mar 9, 2022

Arms and Interventions

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%
  • Outcome Measures

    Primary Outcome Measures

    1. serum iron level [at day 0 and at day 99]

      Serum iron concentration at days 0 and 99

    Secondary Outcome Measures

    1. Haemoglobin concentration [at day 0 and at day 99]

      Haemoglobin concentration at days 0 and 99

    2. Percentage of infants with anaemia [at day 99]

      Percentage of infants with anaemia (defined as: Hb< 110g/L, )

    3. breast feeding [weekly up to week 14]

      Duration of breast feeding assessed weekly, up to study day 98.

    4. maternal reported illnesses [daily up to day 99]

      Proportion of maternal-reported illnesses assessed daily up to study day 99.

    5. adverse events assessment [daily up to day 99]

      Proportion of adverse events assessed daily, up to study day 99

    6. Serious adverse events (SAE) assessment [daily up to day 99]

      Proportion of serious adverse events assessed daily, up to study day 99

    7. raised inflammatory markers assessment [after 98 days of supplementation]

      Proportion of raised inflammatory markers (CRP/AGP)

    8. 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 [at day 0 and day 99]

      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)

    9. Fecal iron after supplementation [day 0 and day 99]

      Fecal iron assessed at day 0 and day 99

    10. Iron regulation [day 0 and day 99]

      Hepcidin levels at day 0 and day 99

    11. Reticulocytes at day 0 and day 99 [day 0 and day 99]

      Reticulocytes at day 0 and day 99

    12. Erythropoietin at days 0 and 99 [day 0 and 99]

      Erythropoietin at days 0 and 99

    13. Erythroferrone at days 0 and 99 [day 0 and 99]

      Erythroferrone at days 0 and 99

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Weeks to 10 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Keneba Field Station Keneba Gambia

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    London School of Hygiene and Tropical Medicine
    ClinicalTrials.gov Identifier:
    NCT04751994
    Other Study ID Numbers:
    • LEO 19092
    First Posted:
    Feb 12, 2021
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by London School of Hygiene and Tropical Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 26, 2022