Vitamin D Supplementation for the Prevention of GDM

Early Phase 1

Recruiting

• Conditions: Vitamin D; Gestational Diabetes
• Interventions: Drug: The placebo(not contain vitamin D); Drug: Vitamin D3

• Registration Number: NCT05208827
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-24
• Status Verified: 2022-01
• Study Start: 2022-01-01
• Study First Submitted QC: 2022-01-11
• Last Update Submitted: 2022-01-11
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1600

Inclusion Criteria

• 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. -

Exclusion Criteria

• 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; 7. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	The placebo(not contain vitamin D)	The control group received the same packaged, similar-looking, similar-tasting placebo from the same manufacturer, containing starch, peanut oil (no pharmaceutical value)
Experimental group	Vitamin D3	Take two tablets once a day.Each tablet contains 800 units of vitamin D3, for a total of 1600 units taken orally daily

Primary Outcome Measures

Name	Time	Method
Gestational diabetes	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) .

Secondary Outcome Measures

Name	Time	Method
Newborn birth weight	immediately after delivery	Weight of newborn at birth
Gestational age	immediately after delivery	Determine the gestational age of the woman and whether preterm birth exists
Weight gain during pregnancy	First day after birth	Weigh the pregnant woman on the first day after delivery and subtract her weight before pregnancy from the birth examination book

Trial Locations

Locations (1)

Women's Hospital School of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China