Iron Babies Pilot Supplementation Trial
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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Placebo Comparator: supplement with placebo administration of daily placebo drops |
Dietary Supplement: Placebo drops
Participants will consume daily drops of placebo
Other Names:
|
Outcome Measures
Primary Outcome Measures
- serum iron level [at day 0 and at day 99]
Serum iron concentration at days 0 and 99
Secondary Outcome Measures
- Haemoglobin concentration [at day 0 and at day 99]
Haemoglobin concentration at days 0 and 99
- Percentage of infants with anaemia [at day 99]
Percentage of infants with anaemia (defined as: Hb< 110g/L, )
- breast feeding [weekly up to week 14]
Duration of breast feeding assessed weekly, up to study day 98.
- maternal reported illnesses [daily up to day 99]
Proportion of maternal-reported illnesses assessed daily up to study day 99.
- adverse events assessment [daily up to day 99]
Proportion of adverse events 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
- raised inflammatory markers assessment [after 98 days of supplementation]
Proportion of raised inflammatory markers (CRP/AGP)
- 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)
- Fecal iron after supplementation [day 0 and day 99]
Fecal iron assessed at day 0 and day 99
- Iron regulation [day 0 and day 99]
Hepcidin levels at day 0 and day 99
- Reticulocytes at day 0 and day 99 [day 0 and day 99]
Reticulocytes at day 0 and day 99
- Erythropoietin at days 0 and 99 [day 0 and 99]
Erythropoietin at days 0 and 99
- Erythroferrone at days 0 and 99 [day 0 and 99]
Erythroferrone at days 0 and 99
Eligibility Criteria
Criteria
Inclusion Criteria:
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Infants (male or female) from 6 weeks to 10 weeks of age.
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Breast fed infants (with plans to continue breastfeeding through 6 months of age).
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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).
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Healthy with no current illness and no chronic health problems.
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Signed or fingerprinted informed consent obtained from participants parent/guardian
Exclusion Criteria:
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Low birthweight babies (ie less than 2.5kg at birth) or babies born prematurely (ie less than 37 weeks) will NOT be excluded.
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Formula fed infants or those planning to terminate exclusive breast feeding before 6months of age.
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Acute illness (once acute illness is resolved, if appropriate, as per investigator assessment, participant may be re-revaluated for eligibility)
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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).
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Administration of any investigational drug within 30 days prior to study initiation or planned administration during the study period.
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Unwilling to avoid (their child to avoid) the ingestion of supplements or herbal/other traditional medications during the study period.
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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).
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Any history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections.
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History of meningitis, seizures, Guillain-Barré syndrome, or other neurological disorders.
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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 | |
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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.- LEO 19092