Vitamin D Supplementation for the Prevention of GDM

  • End date
    Jan 1, 2025
  • participants needed
  • sponsor
    Women's Hospital School Of Medicine Zhejiang University
Updated on 22 March 2022
fasting blood glucose
vitamin d
hemoglobin a1c
Accepts healthy volunteers


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


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.

Condition Vitamin D, Gestational Diabetes
Treatment Vitamin D3, The placebo(not contain vitamin D)
Clinical Study IdentifierNCT05208827
SponsorWomen's Hospital School Of Medicine Zhejiang University
Last Modified on22 March 2022


Yes No Not Sure

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
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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
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