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A multicenter randomized controlled study of vitamin D supplementation in pregnant women for the prevention of gestational diabetes

A multicenter randomized controlled study of vitamin D supplementation in pregnant women for the prevention of gestational diabetes - VDPGDM

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032488
Enrollment
Unknown
Registered
2020-04-29
Start date
2020-09-28
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gestational diabetes mellitus

Interventions

Control group:Placebo 2 pills per day
Intervention group:800 IU vitamin D3, 2 pills per day

Sponsors

Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. First visit of 8~14 gestational week; 2. Age: 18-45 years old; 3. Pregnant women who are at high risk of GDM (pregnant women who meet any of the following conditions defined as have high risk of GDM): (1) Pre-pregnancy or early pregnancy BMI >= 24kg /m^2; (2) Family history of diabetes or GDM; (3) GDM diagnosed in previous pregnancies; (4) History of childbirth of macrosomia ( >= 4000 g); (5) History of impaired glucose tolerance: HbA1c 5.7–6.4% or fasting plasma glucose 6.1–7.0 mmol/L; 4. Agree to participate in the program and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Participants with a history of diabetes or diagnosis of diabetes (including type 1 and type 2 diabetes); 2. Glycosylated hemoglobin >= 6.5% or fasting blood glucose >7.0 mmol/L accompanied by obvious symptoms of diabetes; 3. Hypercalcemia; 4. Daily vitamin D intake >1000 IU or daily vitamin D intake <=1000 IU but unwilling to discontinue existing vitamin D supplementation; 5. Cardiac, pulmonary, hepatic, or renal insufficiency; 6. Suffering from other major diseases; 7. Multiple pregnancies or assisted reproductive technology conception; 8. Currently participating in other clinical trials; 9. Other conditions deemed by investigators as unsuitable for clinical trial participation.

Design outcomes

Primary

MeasureTime frame
gestational diabetes mellitus;Infant diseases;—

Secondary

MeasureTime frame
birthweight;Insulin;HbA1c;FBG;PBG1H;PBG2H;Birth gestational age;Birth head circumference;Abnormal labor;Mode of delivery;Neonatal diseases;Pregnancy complications;Abortion;Postpartum hypertension;Puerperal infection;Infant weight;Infant length;—

Countries

China

Contacts

Public ContactYu Yunxian

Zhejiang University

yunxianyu@zju.edu.cn+86 137 3587 5136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 26, 2026