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临床试验/CTRI/2013/10/004056
CTRI/2013/10/004056招募中3 期

Vitamin D deficiency in pregnancy: Its prevalence and role of supplementation in preventing adverse maternal and fetal outcome: A double blind randomized placebo-controlled trial.

CSIR1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2010年11月19日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
CSIR
入组人数
280
试验地点
1
主要终点
Incidence of

研究概览

简要总结

This study is a randomized, double blind, parallel group, single- centre trial to study the role of vitamin D supplementation during pregnancy in preventing adverse maternal and fetal outcomes. Planned to enroll 280 women. Vitamin D level will be assessed. Patients will be randomized to receive 60000 IU/d of vitamin D for 5 days or a similar looking placebo for 5 days. All the women will be followed through pregnancy and incidence of preeclampsia, gestational diabetes mellitus, gall bladder dysfunction and intrauterine growth restriction, duration of gestation will be compared in either groups. At birth neonatal anthropometry and apgar score will be compared between two groups

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • •Inclusion Criteria: Singleton pregnancy normotensive.

排除标准

  • •?Pre- existing medical conditions like rheumatoid arthritis, thyroid, parathyroid or adrenal diseases, hepatic or renal failure, metabolic bone disease, diabetes mellitus, malabsorption, essential hypertension?Medications influencing bone, vitamin D or calcium metabolism?Preexisting gall bladder disease.

结局指标

主要结局

Incidence of

时间窗: Through pregnancy | delivery

Gestational Diabetes Mellitus

时间窗: Through pregnancy | delivery

Preeclampsia

时间窗: Through pregnancy | delivery

Gall bladder dysfunction

时间窗: Through pregnancy | delivery

Intra Uterine Growth Restriction

时间窗: Through pregnancy | delivery

次要结局

  • Prevalence of vitamin D deficiency(Effect of vitamin D supplementation on labor and delivery)

研究者

发起方
CSIR
申办方类型
Government funding agency

研究点 (1)

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