A Randomized Control Double Blind Parallel group without Placebo Clinical Trial to look the antropometric outcome of Vitamin B12 supplementation in children with severe acute malnutrition(SAM) aged b1 month to 60 months in Nutritional Rehabilitation Center

Moti Lal Nehru Medical College Allahabad1 个研究点分布在 1 个国家目标入组 180 人开始时间: 2023年3月10日最近更新: 2023年9月21日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 180
试验地点: 1
主要终点: change in anthropometric parameters ( weight and height) after vitamin B12 supplementation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Vitamin B12 defficiency is commonly associated in children with severe acute malnutrition and is not used as routine supplements according to WHO guidelines of management of severe acute malnutrition in facility.Vitamin B12 and folate deficiency leads to megaloblastic anemia, poor growth and increased infections.We aim to look for the effect of vitamin B12 supplementation of anthropometric indices and improvement of anemia in children with severe acute malnutrition

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 1.00 Month(s) 至 60.00 Month(s)（—）
性别: All

入选标准

•1.Parents or guardians willing to give written informed consent 2.Age group of 1 month to 60 month children with severe acute malnutrition(SAM) 3.SAM will be defined as : Mid upper arm circumference (MUAC) <11.5 cm and/or weight for height/length <-3 standard deviation and/or bilateral pitting edema.

排除标准

•All children with non-nutritional anaemia (malignancy,haemolytic anaemia and aplastic anaemia)
•Children diagnosed to have chronic liver disease, chronic kidney disease, GIT disorder(inflammatory bowel disorders),heart disease,infantile tremor syndrome
•Children with unstable viatals.

结局指标

主要结局

change in anthropometric parameters ( weight and height) after vitamin B12 supplementation

时间窗: 1 year

次要结局

1.Document changes in Hb levels and MCV levels(2.Describe the prevalence of anemia in enrolled patients)

研究者

发起方

Moti Lal Nehru Medical College Allahabad

申办方类型

Government medical college

研究点 (1)

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