Status:
UNKNOWN
Vitamin D Supplementation for the Prevention of GDM
Lead Sponsor:
Women's Hospital School Of Medicine Zhejiang University
Conditions:
Vitamin D
Gestational Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT05208827
Start Date
January 1 2022
End Date
January 1 2025
Last Update
January 26 2022
Active Locations (1)
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1
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310000