Vitamin D Supplementation for the Prevention of GDM

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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.