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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05208827
Other study ID # GDM20211008
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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