This study was a double-blind multicenter randomized controlled study.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,600
Participants began to take medication at 12 weeks of gestation, and participants in the second trimester began to take medication at the time point of enrollment.The dosage is 2 tablets per day, taken orally for 12 weeks.The drug in the intervention group was fat-soluble vitamin D3, which was produced by Sinopril Holding Starfish Pharmaceutical (Xiamen) Co., LTD. Each tablet contained 800 units of vitamin D3, vegetable oil and starch as auxiliary material.
Pills that looked, colored and tasted like vitamin D in the control group, but contained only starch and vegetable oil and no vitamin D.
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGGestational diabetes
We will judge whether patients have gestational diabetes based on OGTT results (fasting, 1-hour, 2-hour blood glucose results) .
Time frame: At 24-28 weeks of gestation
Newborn birth weight
Weight of newborn at birth
Time frame: immediately after delivery
Gestational age
Determine the gestational age of the woman and whether preterm birth exists
Time frame: immediately after delivery
Weight gain during pregnancy
Weigh the pregnant woman on the first day after delivery and subtract her weight before pregnancy from the birth examination book
Time frame: First day after birth
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