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.
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)
