Iron Bioavailability From Fortified Cereal in Malawian Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C).
研究概览
简要总结
The overall objective of this trial is to investigate the iron bioavailability from new infant cereals in Malawian infants.
详细描述
In 30 infants aged 6 to 14 months old, the investigator will administer in random order over 2 phases separated by 14 days, 5 infant cereals containing either ferrous fumarate (4 meals) or ferrous bisglycinate (1 meal) intrinsically labeled with stable isotopes. The investigator will collect one blood sample at baseline and another sample at the end of each phase, thus 3 samples total. In these samples, fractional iron absorption and markers of iron and inflammation status will be measured . In addition, infant and child acceptability of one of the infant cereals will be assessed by using a questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 14 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant age 6 - 14 months
- •Infant exhibits no clinical signs / symptoms of chronic disease or acute illness
- •Capillary haemoglobin concentration > 70g/L
- •Z-scores for weight-for-age and weight-for-length > -2
- •Infant's parent(s) / legally acceptable representative is of legal age of consent, has anticipated residence in the area for the duration of the study, and is willing and able to fulfil the requirements of the study protocol
- •Infant is expected to consume the entire 25 g portion during infant cereal feeding based on the Investigator's judgement established via observations of feeding during the adaptation phase
- •Infant received a complete dose of intermittent preventive treatment with dihydroartemisinin piperaquine (IPTi-DP) as well a single dose of antihelminth treatment with Albendazole
排除标准
- •Parents not willing / not able to comply with the requirements of study protocol
- •Infants receiving iron-containing supplements in the 2 months prior to enrollment (other supplements are acceptable)
- •Infants with allergies or intolerance to wheat, oat, gluten or other ingredients in the test cereals (e.g., celiac disease)
- •Infants participating in any other clinical trial prior to enrollment
- •Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures.
研究组 & 干预措施
Testmeal A
A new, whole-grain infant cereal fortified with ferrous fumarate
干预措施: Labeled iron salt Fe54 (Other)
Testmeal B
An alternative new whole-grain infant cereal recipe fortified with ferrous fumarate
干预措施: Labeled iron salt Fe57 (Other)
Testmeal C
An existing, refined grain infant cereal fortified with ferrous fumarate
干预措施: Labeled iron salt Fe54 (Other)
Testmeal D
An existing, whole-grain infant cereal fortified with ferrous fumarate
干预措施: Labeled iron salt Fe57 (Other)
Testmeal E
An existing, whole-grain infant cereal fortified with ferrous bisglycinate
干预措施: Labeled iron salt Fe58 (Other)
结局指标
主要结局
Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C).
时间窗: up to 6 weeks
Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C). Based on the shift of Fe isotope ratios in the blood samples and the amount of Fe circulating in the body, the amounts of 54Fe and 57Fe isotopic label present in the blood 14 days after the test meal administrations will be calculated on the principle of isotope dilution and considering that the iron isotopic labels are not mono-isotopic
次要结局
- Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E).(up to 6 weeks)
- Cereal acceptability questionnaire(up to 2 weeks)
- Fractional iron absorption from infants with (CRP ≥ 10 mg/L) or without (CRP < 10 mg/L) asymptomatic infection / inflammation.(up to 6 weeks)
- Standard reporting of adverse events (AEs) for safety assessment(time of consent to 24 hours after final blood draw)