Vitamin D Supplementation for the Prevention of GDM

Women's Hospital School Of Medicine Zhejiang University

Status and phase: Enrolling; Early Phase 1

Conditions: Gestational Diabetes; Vitamin D

Treatments: Drug: Vitamin D3; Drug: The placebo(not contain vitamin D)

Study type: Interventional

Funder types: Other

Identifiers

NCT05208827

GDM20211008

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,600 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,600 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

Take two tablets once a day.Each tablet contains 800 units of vitamin D3, for a total of 1600 units taken orally daily

Treatment:

Drug: Vitamin D3

Control Group

Placebo Comparator group

Description:

The control group received the same packaged, similar-looking, similar-tasting placebo from the same manufacturer, containing starch, peanut oil (no pharmaceutical value)

Treatment:

Drug: The placebo(not contain vitamin D)