Iron Babies Pilot Supplementation Trial
- Conditions
- Iron-deficiencyAnaemia in Early Infancy
- Interventions
- Dietary Supplement: Iron drops/Ferrous sulphateDietary Supplement: Placebo drops
- Registration Number
- NCT04751994
- Lead Sponsor
- London School of Hygiene and Tropical Medicine
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iron supplement/ ferrous sulphate syrup Iron drops/Ferrous sulphate administration of daily iron drops, 7.5mg/day iron as ferrous sulphate supplement with placebo Placebo drops administration of daily placebo drops
- Primary Outcome Measures
Name Time Method serum iron level at day 0 and at day 99 Serum iron concentration at days 0 and 99
- Secondary Outcome Measures
Name Time Method maternal reported illnesses daily up to day 99 Proportion of maternal-reported illnesses assessed daily up to study day 99.
Serious adverse events (SAE) assessment daily up to day 99 Proportion of serious adverse events assessed daily, up to study day 99
Erythroferrone at days 0 and 99 day 0 and 99 Erythroferrone at days 0 and 99
adverse events assessment daily up to day 99 Proportion of adverse events assessed daily, up to study day 99
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)
Iron regulation day 0 and day 99 Hepcidin levels at day 0 and day 99
Percentage of infants with anaemia at day 99 Percentage of infants with anaemia (defined as: Hb\< 110g/L, )
raised inflammatory markers assessment after 98 days of supplementation Proportion of raised inflammatory markers (CRP/AGP)
Fecal iron after supplementation day 0 and day 99 Fecal iron assessed at day 0 and day 99
breast feeding weekly up to week 14 Duration of breast feeding assessed weekly, up to study day 98.
Reticulocytes at day 0 and day 99 day 0 and day 99 Reticulocytes at day 0 and day 99
Haemoglobin concentration at day 0 and at day 99 Haemoglobin concentration at days 0 and 99
Erythropoietin at days 0 and 99 day 0 and 99 Erythropoietin at days 0 and 99
Trial Locations
- Locations (1)
Keneba Field Station
🇬🇲Keneba, Gambia