NCT00554814暂停不适用
Interest of Biofer ® Compound Used in Blédilait Follow on Milk and Growing Milk on Iron Status Evolution in Infant With Latent Iron Deficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Bledina
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Serum ferritin value measured after 2 months of studied milks consumption.
研究概览
简要总结
The primary purpose of the study is to demonstrate the superiority of Bledilait milk (Biofer® 2mg/100kcal) in comparison with ferrous sulphate supplemented milk (2 mg/100 kcal) in infants (6 to 12 months) with latent iron deficiency by measuring serum ferritin value after 2 months of consumption of studied milks.
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)
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infant between 6 and 12 months of age,
- •preterm infant, low birth weight infant (< 2,5 kg), multiple pregnancy, infant from mother with close pregnancies (2 babies in 2 years),
- •infant with a serum ferritin value < 12ng/ml and with a normal haemoglobin value (> 11 g/dl), i.e. with a latent iron deficiency,
- •infant whose parents or legal tutors have given written informed consent,
- •parents or legal tutors agreeing for 4 month follow-up by the investigator,
- •infant for which a clinical exam has been performed,
- •infant with health insurance.
排除标准
- •infant with serum ferritin value < 12 ng/ml and haemoglobin value < 11 g/dl
- •infant already receiving medicinal iron supplementation,
- •infant with acquired or congenital defect,
- •infant presenting a significant metabolic, organic or digestive disease able to interfere with study (including hemochromatosis)
- •infant with congenital and/or chromosomal malformation
- •infant receiving a drug susceptible, according to the investigator, to interfere with the measured study parameters
- •infant needing specific infant formula (hypoallergenic, without cow milk proteins)
- •infant in a situation that could, according to investigator, interfere with an optimal participation to the study or be a health risk
研究组 & 干预措施
3
Experimental
Blédilait Biofer® milk (1,1mg/100kcal)
干预措施: Blédilait Biofer® (Drug)
1
Experimental
Blédilait Biofer® milk (2mg/100kcal)
干预措施: Bledilait Biofer® (Drug)
2
Active Comparator
Milk supplemented with ferrous sulphate (2mg/100kcal)
干预措施: Milk supplemented with ferrous sulphate (Drug)
结局指标
主要结局
Serum ferritin value measured after 2 months of studied milks consumption.
时间窗: 2 months
次要结局
- - Serum ferritin value - Serum ferritin evolution - CMV evolution - Red blood cells evolution - Common Infectious diseases - Antibiotic consumption(baseline, baseline + 2 months, baseline + 4 months)
研究者
研究点 (1)
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