Oral Vitamin D supplementation as a safe, affordable treatment for profound vitamin D deficiency inpregnancy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To perform an open label study of 2000IU vitamin D3/d supplementation
研究概览
简要总结
Global evidence that vitamin D sufficiency from early pregnancy, potentially pre-conception, till term
is safe and beneficially impacts maternal and neonatal outcomes are increasingly compelling.
However, concerns exist across India related to safety and efficacy in pregnancy of >400-500 IU/d
vitamin D during pregnancy. Our study aims to address these concerns directly through a pilot
intervention study of supplementing 2000IU vitamin D3/d during pregnancy, though building a cross-
India consortium and discussion with international experts to capacity build, train, debate and
subsequently plan a large-scale multi-center study in India with potential to address a range of
clinical and mechanistic outcomes. Correcting the profound levels of deficiency in pregnancy in
LMIC such as India reflects an affordable and safe intervention with a potentially major public health
impact in improving maternal and infant outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Apparent healthy pregnant woman (18-40 years), before 13 weeks of gestation, willing to give informed consent, oblige to protocol regime, consume assigned supplement, and give blood samples.
排除标准
- •Pregnant women with twins or multiple pregnancies, chronic morbidities, on medication or undergoing treatment, or consuming multi-vitamins, have infections such as HIV, VDRL, HBsAg, assisted pregnancy, or anticipate discontinuing or moving out of the study site.
结局指标
主要结局
To perform an open label study of 2000IU vitamin D3/d supplementation
时间窗: Assessment of Total Vitamin D, PTH levels in maternal venous blood during pregnancy (14, 24 and 34 weeks of gestation). | from second trimester of pregnancy until delivery to determine whether | this supplemental dose results in vitamin D repletion after intervention
from second trimester of pregnancy until delivery to determine whether
时间窗: Assessment of Total Vitamin D, PTH levels in maternal venous blood during pregnancy (14, 24 and 34 weeks of gestation). | from second trimester of pregnancy until delivery to determine whether | this supplemental dose results in vitamin D repletion after intervention
this supplemental dose results in vitamin D repletion after intervention
时间窗: Assessment of Total Vitamin D, PTH levels in maternal venous blood during pregnancy (14, 24 and 34 weeks of gestation). | from second trimester of pregnancy until delivery to determine whether | this supplemental dose results in vitamin D repletion after intervention
次要结局
- To evaluate the innate immunity in the newborn of the mothers(supplemented with 2000IU vitamin D3 during pregnancy)