CTRI/2014/06/004670招募中未知
A Randomized Controlled Trial to Investigate the Effects of Vitamin D supplementation on maternal and new-born babyâ??s vitamin D status in Asian-Indian Subjects. - VIDIMA
Indian Council of Medical Research ICMR0 个研究点目标入组 368 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 368
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Pregnant women between 12-16 weeks of gestation.
- •Age between 18 to 35 years.
- •Subjects agrees for delivery conducted at the AIIMS
排除标准
- •Subjects will be excluded from the study if they
- •Have more than one gestation in current pregnancy
- •Complicated medical or obstetric history that may increase the risk of preterm birth or labor/ delivery complications, based on self-report or clinical assessment by obstetrician (cardiovascular disease, more than three abortions ,hypertension, preeclampsia or Rh isoimmunization)
- •Prior history of delivery of an infant with chromosomal abnormalities or IUGR in previous pregnancy
- •Presence of any diagnosed systemic disease known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism.
- •Have features suggestive of osteomalacia or severe VDD.
- •Pre-existing hypertension
- •Already diagnosed with diabetes (type 1 or 2)
- •Are taking or had taken vitamin D supplementation in last two months in doses exceeding 600 IU/day.
- •Are using medications known to interact with vitamin D metabolism (steroids,thiazide diuretics, phenytoin, phenobarbitone and antitubercular drugs).
- •Have known hypersensitivity to Vitamin D
- •preparations.
- •Have participated in any other investigational drug study in previous three months.
- •Have past history of bariatric surgery.
- •Are using Ultra-Violet (UV) radiations as a part of medical therapy.
- •Are diagnosed with albinism or have other condition associated with decreased skin pigmentation.
- •Have any medical condition that in the judgment of the investigator would jeopardize the subjectâ??s safety or evaluation of study drug for efficacy or safety .
- •Additional exclusion criteria will be applied after biochemical screening:
- •Having gestational diabetes between 12-16 weeks of pregnancy.
- •Have serum calcium more than 1 mg/dL above the upper limit of normal for age.
- •Have serum S.25(OH)D level more than 100 ng/mL.
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