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

Gestational Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03138616
• Other study ID #: 20160901
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: May 1, 2017
• Last updated: May 5, 2017
• Start date: November 1, 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: May 2017
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: January 31, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Drug:
• vitamin D
take 1600 units of vitamin D daily for nine months

Locations

Country	Name	City	State
China	Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (4)

Mitri J, Dawson-Hughes B, Hu FB, Pittas AG. Effects of vitamin D and calcium supplementation on pancreatic ß cell function, insulin sensitivity, and glycemia in adults at high risk of diabetes: the Calcium and Vitamin D for Diabetes Mellitus (CaDDM) randomized controlled trial. Am J Clin Nutr. 2011 Aug;94(2):486-94. doi: 10.3945/ajcn.111.011684. Epub 2011 Jun 29. — View Citation

Nsiah-Kumi PA, Erickson JM, Beals JL, Ogle EA, Whiting M, Brushbreaker C, Borgeson CD, Qiu F, Yu F, Larsen JL. Vitamin D insufficiency is associated with diabetes risk in Native American children. Clin Pediatr (Phila). 2012 Feb;51(2):146-53. doi: 10.1177/0009922811417290. Epub 2011 Oct 20. — View Citation

Pleskacová A, Bartáková V, Pácal L, Kuricová K, Belobrádková J, Tomandl J, Kanková K. Vitamin D Status in Women with Gestational Diabetes Mellitus during Pregnancy and Postpartum. Biomed Res Int. 2015;2015:260624. doi: 10.1155/2015/260624. Epub 2015 Apr 27. — View Citation

von Hurst PR, Stonehouse W, Coad J. Vitamin D supplementation reduces insulin resistance in South Asian women living in New Zealand who are insulin resistant and vitamin D deficient - a randomised, placebo-controlled trial. Br J Nutr. 2010 Feb;103(4):549-55. doi: 10.1017/S0007114509992017. Epub 2009 Sep 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glucose metabolism	change in Insulin sensitivity index,insulin resistance,inflammatory factors	9 months
Secondary	change in Lipid metabolism	change in triglyceride,cholesterol,HDL,LDL and FFA(free fatty acid)	9 months
Secondary	change in metabolism of calcium and phosphorus	change in calcium, phosphorus,the ratio of urine calcium and creatinine	9 months