A Multicenter Randomized Controlled Study of Vitamin D Supplementation in Pregnant Women for the Prevention of Gestational Diabetes
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Gestational diabetes
研究概览
简要总结
This study was a double-blind multicenter randomized controlled study.
详细描述
This study intends to adopt a randomized controlled study design, and randomly divide pregnant women at high risk of GDM into intervention group (VitD3:1600 IU/ day) (n=800) and control group (placebo:2 tablets/day) (n=800) until the end of delivery. The risk of GDM in pregnant women of the two groups was compared, the preventive effect of high-dose VitD supplementation during pregnancy on different subtypes of GDM was determined, and the effects of VitD supplementation on VitD nutritional status during pregnancy and birth outcome and health of offspring were explored, so as to provide evidence-based basis for rational VitD supplementation during pregnancy.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who are 8 to 14 weeks pregnant ; ② 18 to 45 years old; ③ Pregnant women at high risk of GDM (meeting any of the following conditions) : A) BMI ≥24 kg/m2 before or during pregnancy; B) family history of diabetes or GDM; C) Previous pregnancy diagnosed as GDM; D) with a history of macrosomia (≥4000 g); E) A history of abnormal glucose tolerance: 5.7-6.4% hBA1c or 6.1-7.0 mmol/L fasting blood glucose.
- •Sign informed consent. -
排除标准
- •Patients with a history of diabetes or currently diagnosed diabetes (including type 1 and type 2 diabetes);
- •HBA1c ≥6.5% or fasting blood glucose & GT;7.0 mmol/L with obvious symptoms of diabetes;
- •Patients with current or past abnormalities in calcium metabolism (hypoparathyroidism/hyperthyroidism, kidney stones), high urinary calcium or hypercalcemia;
- •Daily VitD intake & GT;800 IU. ⑤ Suffering from serious chronic diseases (heart, lung, liver, kidney and other dysfunction) or mental illness;
- •They cannot walk 100 meters safely;
- •Multiple pregnancies or assisted reproduction; ⑧ need complex diet;
- •Cannot speak Mandarin fluently; ⑩ Those who are participating in other clinical trials or who are considered unsuitable for clinical trials by researchers for other reasons.
研究组 & 干预措施
Experimental group
Take two tablets once a day.Each tablet contains 800 units of vitamin D3, for a total of 1600 units taken orally daily
干预措施: Vitamin D3 (Drug)
Control Group
The control group received the same packaged, similar-looking, similar-tasting placebo from the same manufacturer, containing starch, peanut oil (no pharmaceutical value)
干预措施: The placebo(not contain vitamin D) (Drug)
结局指标
主要结局
Gestational diabetes
时间窗: At 24-28 weeks of gestation
We will judge whether patients have gestational diabetes based on OGTT results (fasting, 1-hour, 2-hour blood glucose results) .
次要结局
- Newborn birth weight(immediately after delivery)
- Gestational age(immediately after delivery)
- Weight gain during pregnancy(First day after birth)