NCT05670002已完成不适用
Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of At Risk and Stunted Children Aged Between 12-36 Months
FrieslandCampina1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2022年11月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Linear growth
研究概览
简要总结
This is a non-randomized open label 6 months intervention study that aims to assess the effectiveness of consuming milk daily for 6 months will improve the linear growth rate of children aged 12-36 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Malaysian child
- •Boys and girls between the age of 12 and 36 months
- •Length-for-age z score (LAZ) <-1.5 SD and > -3 SD according to the WHO Growth standard
- •Weight-for-age z score WAZ <1.0 SD and > -3 SD
- •Parents and/or legal guardian who can speak and read Malay or English language
- •Written informed consent from parents and/or legal guardian
- •Child who are apparently healthy with no obvious on-going infection and no history of chronic illness.
- •Child with no physical and/or mental illness
- •Parents and/or legal guardian who owns a mobile phone or smart phone
- •Mothers who have ever received breastfeeding counselling from a qualified breastfeeding counsellor.
排除标准
- •Child with zinc protoporphyrin (ZnPP) value of >65 (at either -T3 or T0)
- •Clinical symptoms of iron deficiency as examined by Doctor even with zinc protoporphyrin (ZnPP) value between 40-64
- •Child with severe acute malnutrition, other chronic diseases or any congenital disorder or deformity
- •Child with an ongoing episode of diarrhoea or a history of persistent diarrhoea in the past month
- •Child with history of cow's milk allergy/intolerance to milk
- •Child who is already taking multivitamins, including iron, before enrolled to the study
- •Child who is taking breastmilk as part of the diet
结局指标
主要结局
Linear growth
时间窗: 6 months
Change in LAZ/HAZ z-score from baseline to after 6 months of intervention
次要结局
- Zinc Protoporphyrin (ZnPP) levels(9 months)
- Growth velocity(9 months)
研究者
研究点 (1)
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