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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03138616
Recruitment Status : Unknown
Verified May 2017 by Yufan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Enrolling by invitation
First Posted : May 3, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Yufan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Drug: vitamin D Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: intervention group and control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

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.




Primary Outcome Measures :
  1. Change in glucose metabolism [ Time Frame: 9 months ]
    change in Insulin sensitivity index,insulin resistance,inflammatory factors


Secondary Outcome Measures :
  1. change in Lipid metabolism [ Time Frame: 9 months ]
    change in triglyceride,cholesterol,HDL,LDL and FFA(free fatty acid)

  2. change in metabolism of calcium and phosphorus [ Time Frame: 9 months ]
    change in calcium, phosphorus,the ratio of urine calcium and creatinine



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants with vitamin D deficiency and previous GDM
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138616


Locations
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China, Shanghai
Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai
Shanghai, Shanghai, China, 200080
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Publications:
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Responsible Party: Yufan Wang, Principal Investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03138616    
Other Study ID Numbers: 20160901
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yufan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
Gestational diabetes mellitus
vitamin D
postpartum
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents