NCT01840384Unknown不适用
Longitudinal Study on the Effect of Multiple Micro Nutrients Supplementation on Haemoglobin Level of 8 to 22-month-old Indonesian Children.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Haemoglobin level
研究概览
简要总结
This study is initiated to investigate the effect of multi micronutrient supplementation for 12 months on serum haemoglobin level in Indonesian young children.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Months 至 10 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy Indonesian infants
- •Age 8-10 month at baseline visit
- •Willing to take 2 sachets of study product per day
- •Planning to reside in the study area during the next 14-16 months
- •Written informed consent by parent(s) or legally acceptable representative (in ICF there is statement that both are agree that child participate in the study)
排除标准
- •Haemoglobin < 8 g/dL at screening visit*.
- •Significant congenital abnormality which according to investigator's clinical judgement will interfere the study conduct and assessment
- •Any known conditions likely to affect nutrient absorption diagnosed by the child's physician
- •Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special formula is required).
- •Any other current or previous illnesses/conditions or intervention which according to investigator's clinical judgement could interfere the study conduct and assessment (e.g. chronic illness or physical or mental handicaps)
- •Regular use of MMN supplements syrup (every day in > 1 week) within two weeks prior to entry into the study.
- •Not intending to use micronutrient supplements during the study
- •Participation in any other studies involving similar investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- •Premature birth (gestational age <37 weeks)
- •Low birth weight (< 2500 g)
- •Severely under nutrition indicated by any of the following criteria: severely stunted: HAZ < -3 SD; severely underweight WAZ <-3 SD; wasted: WHZ <-2 SD
- •*Subject with haemoglobin level (finger prick blood sample) at screening visit between 8-10 g/dL will be given iron syrup supplementation for 1 month. Thereafter, haemoglobin level (whole blood sample) will be checked at baseline visit:
- •If Hb > 10 g/dL, subject is eligible for randomisation
- •If Hb < 10 g/dL, subject is not eligible for randomisation and will be given iron syrup supplementation for 2 months
结局指标
主要结局
Haemoglobin level
时间窗: 12 months
Change in serum haemoglobin level after 12 months of intervention
次要结局
- Anemia prevalence(12 months)
- Anthropometric(24 months of age)
- Micronutrients(12 months)
研究者
研究点 (1)
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