Clinical trial NCT04751994: Iron Babies Pilot Supplementation Trial
Official title: Enhancing Brain Development by Early Iron Supplementation of African Infants: An Enabling Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron-deficiency
Anaemia in Early Infancy
Keywords: anaemia, infant
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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/drug
Primary purpose: PREVENTION

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 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

Eligibility criteria: 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

Primary outcomes:
measure: serum iron level
timeFrame: at day 0 and at day 99
Secondary outcomes:
measure: Haemoglobin concentration
timeFrame: at day 0 and at day 99
measure: Percentage of infants with anaemia
timeFrame: at day 99
measure: breast feeding
timeFrame: weekly up to week 14
measure: maternal reported illnesses
timeFrame: daily up to day 99
measure: adverse events assessment
timeFrame: daily up to day 99
measure: Serious adverse events (SAE) assessment
timeFrame: daily up to day 99
measure: raised inflammatory markers assessment
timeFrame: after 98 days of supplementation
measure: 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
timeFrame: at day 0 and day 99
measure: Fecal iron after supplementation
timeFrame: day 0 and day 99
measure: Iron regulation
timeFrame: day 0 and day 99
measure: Reticulocytes at day 0 and day 99
timeFrame: day 0 and day 99
measure: Erythropoietin at days 0 and 99
timeFrame: day 0 and 99
measure: Erythroferrone at days 0 and 99
timeFrame: day 0 and 99
Other outcomes:
Locations:
city: Keneba
country: Gambia
facility: Keneba Field Station
Study officials:
affiliation: Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine
name: Carla Cerami, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: