Vitamin D Supplementation for the Prevention of GDM

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208827
• Other study ID #: GDM20211008
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2022
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Luyang Han, doctor
• Phone: 18867106248
• Email: 524519232[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant women who are 8 to 14 weeks pregnant ; ? 18 to 45 years old; ? 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. ? 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; ? need complex diet;

• Cannot speak Mandarin fluently; ? Those who are participating in other clinical trials or who are considered unsuitable for clinical trials by researchers for other reasons.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Vitamin D

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational diabetes	We will judge whether patients have gestational diabetes based on OGTT results (fasting, 1-hour, 2-hour blood glucose results) .	At 24-28 weeks of gestation
Secondary	Newborn birth weight	Weight of newborn at birth	immediately after delivery
Secondary	Gestational age	Determine the gestational age of the woman and whether preterm birth exists	immediately after delivery
Secondary	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	First day after birth