A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- incidence of gestational diabetes
研究概览
简要总结
Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.
详细描述
Determine the effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes.
Explore the effect of increased vitamin D supplementation (4000 IU daily + prenatal vitamin), compared to a standard prenatal vitamin, on glycemic control, need for oral hypoglycemic agents and/or insulin, and delivery outcomes among the subset of women who develop gestational diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are currently pregnant and receiving prenatal care at the Women's Health Specialists Clinic (University of Minnesota Physicians) from either MD/DO or CNM providers
- •Subject established prenatal care no later than the completed 12th week of gestation (12 6/7 weeks)
- •Subject possesses as least one of the following characteristics:
- •BMI greater than or equal to 30 kg/m2
- •History of gestational diabetes in a prior pregnancy
- •History of infant with birth weight of 4500g or greater
- •Subject is capable of giving informed consent
排除标准
- •Age less than 18 years
- •Multiple gestation pregnancies (twins, triplets or greater multiples)
- •Vitamin D deficiency (defined as less than 20 ng/mL)
- •Preexisting diabetes mellitus defined as either:
- •pre-existing diagnosis prior to current pregnancy
- •failure of three-hour glucose tolerance test in first trimester of pregnancy
研究组 & 干预措施
Intervention
4000 IU vitamin D3 +prenatal vitamin
干预措施: 4000 IU vitamin D3 (Drug)
结局指标
主要结局
incidence of gestational diabetes
时间窗: Baseline to Delivery of child
effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes.
次要结局
- Apgar score(Birth of child to 5 minutes)
- Prescription for insulin or oral hypoglycemic agents(Baseline to Delivery of child)
- Mode of delivery(Delivery of child)
- Birth weight(Delivery of Child)
- Shoulder Dystocia(Birth of child)