Enhancing Brain Development by Early Iron Supplementation of African Infants: An Enabling Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- serum iron level
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This will be a two-arm, randomised, placebo-controlled double-blind study. Children will be randomised (1:1) to iron drops or placebo arm.
入排标准
- 年龄范围
- 6 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
serum iron level
时间窗: at day 0 and at day 99
Serum iron concentration at days 0 and 99
次要结局
- maternal reported illnesses(daily up to day 99)
- Serious adverse events (SAE) assessment(daily up to day 99)
- Erythroferrone at days 0 and 99(day 0 and 99)
- adverse events assessment(daily up to 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)
- Iron regulation(day 0 and day 99)
- Percentage of infants with anaemia(at day 99)
- raised inflammatory markers assessment(after 98 days of supplementation)
- Fecal iron after supplementation(day 0 and day 99)
- breast feeding(weekly up to week 14)
- Reticulocytes at day 0 and day 99(day 0 and day 99)
- Haemoglobin concentration(at day 0 and at day 99)
- Erythropoietin at days 0 and 99(day 0 and 99)