CTRI/2010/091/000499未知3 期
Vitamin D and calcium nutrition: deficiency and evaluation of supplementation.
Department of endocrinology, SGPGIMS, Lucknow2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 待定
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Neonatal serum calcium
研究概览
简要总结
This is a pilot randomised study to see the efficacy of 2 dose regimens of oral vitamin D3 in pregnant women with regard to the following outcomes, in comparison with women who receive standard therapy of calcium alone: primary outcome: to maintain newborn serum calcium in better range, in other words, in preventing neonatal hypocalcemia; secondary aims: in maintaining better cord blood 25 OHD and alkaline phosphatase, ie, in preventing vitamin D deficiency in the baby, and the harmful effect of its deficiency on baby's bone health. Another secondary outcome: to maintain improved anthropometry of the baby at birth and at ages upto 1 year.
研究设计
- 分配方式
- Random Number Table
- 盲法
- Outcome Assessor Blinded
入排标准
入选标准
- •All pregnant women who attend antenatal clinic of one unit of Queen Mary Hospital, Chhatrapati Sahuji Maharaj Medical University, Lucknow, are recruited as subjects and randomised to receive one of the 2 intervention regimes.
- •Consecutive women who attend antenatal clinic too near term to be included in the study to serve as controls.
排除标准
- •Patients already on calcium or on vitamin D supplementation, on anticonvulsants, on antitubercular treatment or having any medical condition affecting calcium and vitamin D metabolism (e.g. renal or liver disease).
结局指标
主要结局
Neonatal serum calcium
时间窗: At 4 to 6 day of life
次要结局
- Baby weight, length, head circumference, anterior fontanelle diameter(Nine month of age)
- Cord blood 25 OHD3(Birth)
- Cord blood alkaline phosphatase(Birth)
研究者
研究点 (2)
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