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
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
participant will consume daily drops of iron
Participants will consume daily drops of placebo
Keneba Field Station
Keneba, The Gambia
serum iron level
Serum iron concentration at days 0 and 99
Time frame: at day 0 and at day 99
Haemoglobin concentration
Haemoglobin concentration at days 0 and 99
Time frame: at day 0 and at day 99
Percentage of infants with anaemia
Percentage of infants with anaemia (defined as: Hb\< 110g/L, )
Time frame: at day 99
breast feeding
Duration of breast feeding assessed weekly, up to study day 98.
Time frame: weekly up to week 14
maternal reported illnesses
Proportion of maternal-reported illnesses assessed daily up to study day 99.
Time frame: daily up to day 99
adverse events assessment
Proportion of adverse events assessed daily, up to study day 99
Time frame: daily up to day 99
Serious adverse events (SAE) assessment
Proportion of serious adverse events assessed daily, up to study day 99
Time frame: daily up to day 99
raised inflammatory markers assessment
Proportion of raised inflammatory markers (CRP/AGP)
Time frame: 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
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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)
Time frame: at day 0 and day 99
Fecal iron after supplementation
Fecal iron assessed at day 0 and day 99
Time frame: day 0 and day 99
Iron regulation
Hepcidin levels at day 0 and day 99
Time frame: day 0 and day 99
Reticulocytes at day 0 and day 99
Reticulocytes at day 0 and day 99
Time frame: day 0 and day 99
Erythropoietin at days 0 and 99
Erythropoietin at days 0 and 99
Time frame: day 0 and 99
Erythroferrone at days 0 and 99
Erythroferrone at days 0 and 99
Time frame: day 0 and 99