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Vitamin D Supplementation for the Prevention of GDM

Primary Purpose

Vitamin D, Gestational Diabetes

Status

Recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Vitamin D3

The placebo(not contain vitamin D)

About this trial

This is an interventional prevention trial for Vitamin D

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.
- 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. 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.

Sites / Locations

Women's Hospital School of Medicine Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control Group

Arm Description

Take two tablets once a day.Each tablet contains 800 units of vitamin D3, for a total of 1600 units taken orally daily

The control group received the same packaged, similar-looking, similar-tasting placebo from the same manufacturer, containing starch, peanut oil (no pharmaceutical value)

Outcomes

Primary Outcome Measures

Gestational diabetes

We will judge whether patients have gestational diabetes based on OGTT results (fasting, 1-hour, 2-hour blood glucose results) .

Secondary Outcome Measures

Newborn birth weight

Weight of newborn at birth

Gestational age

Determine the gestational age of the woman and whether preterm birth exists

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

Full Information

NCT ID

NCT05208827

First Posted

November 24, 2021

Last Updated

January 11, 2022

Sponsor

Women's Hospital School Of Medicine Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT05208827

Brief Title

Vitamin D Supplementation for the Prevention of GDM

Official Title

A Multicenter Randomized Controlled Study of Vitamin D Supplementation in Pregnant Women for the Prevention of Gestational Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Women's Hospital School Of Medicine Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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: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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D, Gestational Diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled study design

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Take two tablets once a day.Each tablet contains 800 units of vitamin D3, for a total of 1600 units taken orally daily

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

The control group received the same packaged, similar-looking, similar-tasting placebo from the same manufacturer, containing starch, peanut oil (no pharmaceutical value)

Intervention Type

Drug

Intervention Name(s)

Vitamin D3

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

The placebo(not contain vitamin D)

Intervention Description

Pills that looked, colored and tasted like vitamin D in the control group, but contained only starch and vegetable oil and no vitamin D.

Primary Outcome Measure Information:

Title

Gestational diabetes

Description

We will judge whether patients have gestational diabetes based on OGTT results (fasting, 1-hour, 2-hour blood glucose results) .

Time Frame

At 24-28 weeks of gestation

Secondary Outcome Measure Information:

Title

Newborn birth weight

Description

Weight of newborn at birth

Time Frame

immediately after delivery

Title

Gestational age

Description

Determine the gestational age of the woman and whether preterm birth exists

Time Frame

immediately after delivery

Title

Weight gain during pregnancy

Description

Weigh the pregnant woman on the first day after delivery and subtract her weight before pregnancy from the birth examination book

Time Frame

First day after birth

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

This study only applied to women with normal pregnancies

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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. 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luyang Han, doctor

Phone

18867106248

524519232@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danqing Chen, doctor

Organizational Affiliation

Obstetrics and Gynecology Hospital affiliated to Zhejiang University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Women's Hospital School of Medicine Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luyang Han, Dr.

Phone

18867106248

Ext

+86

524519232@163.com

12. IPD Sharing Statement

Learn more about this trial

Vitamin D Supplementation for the Prevention of GDM

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