Vitamin D Supplementation for the Prevention of GDM

NCT05208827 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2022-01-26

No results posted yet for this study

Summary

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

Conditions

  • Vitamin D
  • Gestational Diabetes

Interventions

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.

Sponsors & Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

    lead OTHER

Principal Investigators

  • Danqing Chen, doctor · Obstetrics and Gynecology Hospital affiliated to Zhejiang University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05208827 on ClinicalTrials.gov