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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)
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
November 24, 2021
Last Updated
January 11, 2022
Sponsor
Women's Hospital School Of Medicine Zhejiang University
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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
No
Studies a U.S. FDA-regulated Device Product
No

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
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
Email
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
Email
524519232@163.com

12. IPD Sharing Statement

Learn more about this trial

Vitamin D Supplementation for the Prevention of GDM

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