The Impact of Vitamin D Supplementation on Glucose Metabolism in Chinese Women With Former Gestational Diabetes Mellitus

May 5, 2017 updated by: Yufan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

The Impacts of Vitamin D Supplementation on Glucose Metabolism in Chinese Women With Vitamin D Deficiency and Former Gestational Diabetes Mellitus:A Randomised Control Trial

Vitamin D deficiency are related to insulin resistance and impaired beta-cell function.It is reported that the level of vitamin D is lower during pregnancy and postpartum in the women with Gestational Diabetes Mellitus. The investigators hypothesize that vitamin D supplementation to women after birth with previous gestational diabetes may improve glucose metabolism.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance that is first identified during pregnancy, excluding diabetic patients diagnosed before pregnancy. GDM can not only have an adverse effect on the pregnant women and the developing fetus, but also can have long lasting effects after birth. GDM can elevates risks of abnormal glucose metabolism postpartum. Vitamin D deficiency has been shown to be associated with insulin resistance and impaired β-cell function. Our previous research also implied that the level of vitamin D is much lower in the women of impaired glucose regulation after birth with history of GDM. This prospective randomized, control clinical trial was designed to evaluate the effects of vitamin D administration on insulin resistance and β-cell function among women with vitamin D deficiency（25OHD <50 ng/mL）and previous GDM. Participants with vitamin D deficiency and previous GDM were divided into normal glucose regulation group(NGR) (n=90) and impaired glucose regulation group(IGR)(n=90) according to the oral glucose tolerance test (OGTT) around 42 days postpartum. And each group was further divided into intervention group and control group, Participants in the intervention group took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention. The control group only receive lifestyle intervention. This study aimed to evaluate the impact of vitamin D supplementation on insulin sensitivity, pancreatic β-cell function and markers of inflammation in Chinese women with former GDM and vitamin D insufficiency.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. with previous GDM,40-50 days after birth -
  2. with deficiency of vitamin D(25-(OH)D3<50nmol/L)

Exclusion Criteria:

  1. type 1 diabetes，type 2 diabetes and other type of diabetes
  2. server disfunction of liver and kidney（ALT >100U/L，Cr>132ummol/L）
  3. with mental disease,sever anemia,sever infection,sever heart disease,now is taking asprin, immunosuppressive agent,Antiepileptic drugs
  4. pregnancy or plan to pregnant in one year
  5. can't understand the requirement of this study
  6. disfunction of thyroid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vitamin D intervention group(NGR)

normal glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum.

took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention.
Drug: vitamin D
take 1600 units of vitamin D daily for nine months
No Intervention: control group(NGR)

normal glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum.

only receive lifestyle intervention.
Experimental: vitamin D intervention group(IGR)

impaired glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum.

took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention.
Drug: vitamin D
take 1600 units of vitamin D daily for nine months
No Intervention: control group(IGR)

impaired glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum.

only receive lifestyle intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glucose metabolism
Time Frame: 9 months
change in Insulin sensitivity index,insulin resistance,inflammatory factors
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Lipid metabolism
Time Frame: 9 months
change in triglyceride,cholesterol,HDL,LDL and FFA（free fatty acid）
9 months
change in metabolism of calcium and phosphorus
Time Frame: 9 months
change in calcium, phosphorus,the ratio of urine calcium and creatinine
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

December 30, 2018

Study Completion (Anticipated)

January 31, 2019

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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