NCT05208827

Vitamin D Supplementation for the Prevention of GDM

A Multicenter Randomized Controlled Study of Vitamin D Supplementation in Pregnant Women for the Prevention of Gestational Diabetes

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1,600 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study was a double-blind multicenter randomized controlled study.

Detailed description

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.

Conditions

• Vitamin D
• Gestational Diabetes

Interventions

Type	Name	Description
DRUG	Vitamin D3	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.
DRUG	The placebo(not contain vitamin D)	Pills that looked, colored and tasted like vitamin D in the control group, but contained only starch and vegetable oil and no vitamin D.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2022-01-26
• Last updated: 2022-01-26

Locations

1 site across 1 country: China