Randomized Controlled Trial to Determine the Nutritional Requirement for Vitamin D for Prevention of Deficiency During Pregnancy and in the Early Neonatal Period (D-MAT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Serum 25-hydroxyvitamin D in pregnant women and cord blood
研究概览
简要总结
Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant women.
详细描述
This is a three-arm, parallel, double-blind, placebo-controlled dose-response intervention study with vitamin D3. Women will be recruited prior to 18 weeks of gestation and randomised to receive placebo, 10 or 20 mcg/d of vitamin D3 from baseline visit in their first trimester until delivery. Blood samples will be collected at baseline, midpoint and endpoint of the trial, at 10 week intervals, and from the umbilical cord at delivery. A 25-hydroxyvitamin D concentration of 30 nmol/L will be used to denote vitamin D deficiency. Information on maternal anthropometry, diet, lifestyle, sun exposure, blood pressure, iPTH and serum total calcium will also be reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult (>18 years)
- •No more than 18 weeks gestation
- •In good general health
- •Low risk pregnancy
- •Not consuming >10 mcg/d vitamin D from supplements
排除标准
- •Current smokers
- •Diagnosed hypertension
- •Known high-risk pregnancy
- •Diagnosed medical illness including diabetes mellitus (Types 1 & 2), chronic kidney disease or gastro-intestinal diseases or any illness known to interfere with calcium metabolism (e.g. sarcoidosis).
- •Consumption of medications known to interfere with vitamin D metabolism
- •Consumption of vitamin D (≥ 10 µg/day) or calcium (≥ 650 mg/d) supplements prior to randomization
结局指标
主要结局
Serum 25-hydroxyvitamin D in pregnant women and cord blood
时间窗: Change from 1st through 2nd trimester and at delivery
Analysis of serum 25-hydroxyvitamin D in mothers for blood taken in the first, second and third trimesters and in umbilical cord
次要结局
- Serum total calcium(Change from 1st through 2nd trimester and at delivery)
- Serum Parathyroid Hormone(Change from 1st through 2nd trimester and at delivery)
研究者
Mairead Kiely PhD
Professor of Human Nutrition
University College Cork