Impact of Daily Zinc Supplementation to Infants Born With Low Birth Weight on Mortality and Severe Disease Requiring Hospitalization
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,012
- 试验地点
- 2
- 主要终点
- a) All cause mortality during zinc supplementation over 4 weeks to 6 months of age b) Rate of severe illness requiring hospitalization
研究概览
简要总结
Title: Impact of daily zinc supplementation to infants born with low birth weight on mortality and severe disease requiring hospitalization Background: Zinc supplementation was shown to prevent diarrhea and pneumonia in 6 month to 3 year old children. Little is known about the impact of zinc supplementation of low birth weight (LBW) babies during first 6 months of life.
Objective: The objectives were to determine the impact of daily zinc administration at 1RDA (5 mg) of elemental zinc to LBW infants on severe morbidity requiring hospitalization and on all cause mortality.
Design: In a double blind randomized placebo controlled trial 2012 hospital-born infants with a birth weight <2500 g were randomly assigned to receive zinc or placebo for 6 months. Zinc group received 5 mg elemental zinc as acetate daily from 4 weeks age. Cause specific hospitalization deaths, episodes of diarrhea, acute respiratory infections, other illness, visits to health care providers and hospital OPDs were ascertained by in-depth interview and from documents like prescriptions, hospital tickets, medicine cartons at 3 and 6 months of age.
Results: Number of infants with one or more diarrhea episodes was less by 17% (95% CI: 1% to 35%) in the zinc group but the numbers for ARI were similar in the two groups. The hospitalization rates due to all causes or diarrhea or ARI were similar in the two groups. Twelve in the zinc group and 9 in the placebo group died during 4 weeks to 6 months (p=0.36). We observed no significant difference for gain in weight and length at 3 months and 6 months between the groups. In a subgroup of infants the mean serum zinc concentration in the zinc group was 27% higher (p=0.004) than the placebo group.
Conclusion: Hospital born, low birth weight infants do not seem to derive worthwhile benefit from daily zinc supplementation of recommended dietary allowance for zinc in terms of morbidity and growth during first six months of life.
详细描述
Objectives:
i.To determine the impact of daily administration of 1 RDA (5 mg) of elemental zinc to LBW infants from 4 weeks to 6 months of life on all-cause mortality.
ii.To determine the impact of zinc supplementation on severe morbidity requiring hospitalization.
Rationale:
i.The prevalence of LBW is high in Asia, particularly in South Asian countries like India, Pakistan and Bangladesh. LBW infants have a high neonatal and infant mortality and morbidity rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Weeks 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight at birth less than 2500gm
- •The infant is likely to stay in the city for the next 6 months
- •Absence of gross congenital malformation
排除标准
- •Perinatal illness requiring hospital stay after birth for more than 7 days
- •Written informed consent was not provided by parents
- •Presence of gross congenital anomaly
- •Resides at a distance that makes it difficult to reach for home visit (estimated time to reach in more than 3 hours)
结局指标
主要结局
a) All cause mortality during zinc supplementation over 4 weeks to 6 months of age b) Rate of severe illness requiring hospitalization
时间窗: 4 weeks to 6 months of age for each subject and study
次要结局
- a) Adverse effect of zinc supplementation including diarrhea, vomiting fever and others. b) Impact of zinc on growth(4 weeks to 6 months of age for each child under study)