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临床试验/CTRI/2012/08/002884
CTRI/2012/08/002884已完成不适用

Effectiveness of zinc supplementation to full term normal infants:A community based Double Blind, Randomized, controlled, clinical trial

NATIONAL INSTITUTE OF NUTRITION1 个研究点 分布在 1 个国家目标入组 427 人开始时间: 2003年1月10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
427
试验地点
1
主要终点
Stunting

研究概览

简要总结

The objective of the present study was to test if zinc supplementation initiated early, prevents stunting and promotes optimum body composition in full term infants. Neonates (2-4 months) were enrolled at home. Birth weights were recorded from the delivery records and weights were recorded at enrolment again. Anthropometric data collection like weight, length, head circumference, chest circumference, mid upper arm circumference and skin fold thicknesses at triceps, biceps, subscapular area were collected every three months. Maternal weight and height were recorded 1 month after delivery and every three months. Supplementation of zinc was started from the age of 5 months and continued till the child attained 18 months of age. There were 162 and 154 children in zinc and placebo groups respectively. The total duration of supplementation was for a period of 14 months. The control group of children received only riboflavin 0.5mg per day, whereas the intervention groups received 5 mg of zinc plus riboflavin 0.5mg per day. Blood samples were collected from cubital vein in a sub sample of 70 children at the end of the study, for estimation of Hemoglobin, Zinc, Copper and Vitamin A. Dietary intakes were calculated by 24hours recall method for 78 children. Thirty seven percent of our study mothers were chronically energy deficient. Mean calorie consumption in these infants was 590 cal per day (95% CI 526.3, 653.8) and mean zinc intakes from diets were 0.98 mg/day. Multiple linear regression models demonstrated maternal weight as strong predictor of infants’ weight and length at 18 months age. As expected, diarrhea duration impacted infant’s linear growth and weight gain adversely. Zinc supplementation had no effect on the linear growth, but increased body fat (measure by skin folds) significantly.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
1.00 Day(s) 至 3.00 Month(s)(—)
性别
All

入选标准

  • •Selection criteria included term healthy infant without any obvious congenital anomalies and planning to stay in the study area till the child is of 2 years.

排除标准

  • •Preterm deliveries and infants with congenital abnormalities or birth trauma were excluded from the study.

结局指标

主要结局

Stunting

时间窗: data on length was collected once in 3 months

次要结局

  • Morbidity(data on morbidity was collected once in 15 days)

研究者

发起方
NATIONAL INSTITUTE OF NUTRITION
申办方类型
Research institution

研究点 (1)

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