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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Take two tablets once a day.Each tablet contains 800 units of vitamin D3, for a total of 1600 units taken orally daily |
|
| Control Group | Placebo Comparator | The control group received the same packaged, similar-looking, similar-tasting placebo from the same manufacturer, containing starch, peanut oil (no pharmaceutical value) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Newborn birth weight | Weight of newborn at birth | immediately after delivery |
| Gestational age | Determine the gestational age of the woman and whether preterm birth exists |
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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.
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; â‘§ need complex diet;
This study only applied to women with normal pregnancies
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luyang Han, doctor | Contact | 18867106248 | 524519232@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Danqing Chen, doctor | Obstetrics and Gynecology Hospital affiliated to Zhejiang University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital School of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Randomized controlled study design
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|
| The placebo(not contain vitamin D) | Drug | Pills that looked, colored and tasted like vitamin D in the control group, but contained only starch and vegetable oil and no vitamin D. |
|
| immediately after delivery |
| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |