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

NCT03138616 | Unknown Phase 4 DMC

• 1 other identifier: 20160901
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational diabetes mellitus; vitamin D; postpartum

Outcome Measures

Primary Outcomes (1)

• Change in glucose metabolism

  change in Insulin sensitivity index,insulin resistance,inflammatory factors

  9 months

Secondary Outcomes (2)

• change in Lipid metabolism

  9 months

• change in metabolism of calcium and phosphorus

  9 months

Study Arms (4)

vitamin D intervention group(NGR)

EXPERIMENTAL

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

control group(NGR)

NO INTERVENTION

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

vitamin D intervention group(IGR)

EXPERIMENTAL

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

control group(IGR)

NO INTERVENTION

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

Interventions

vitamin D DRUG

take 1600 units of vitamin D daily for nine months

vitamin D intervention group(IGR); vitamin D intervention group(NGR)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Participants with vitamin D deficiency and previous GDM
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (4)

• 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.

  PMID: 22019791 BACKGROUND

• 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.

  PMID: 19781131 BACKGROUND

• Mitri J, Dawson-Hughes B, Hu FB, Pittas AG. Effects of vitamin D and calcium supplementation on pancreatic beta 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.

  PMID: 21715514 BACKGROUND

• Pleskacova A, Bartakova V, Pacal L, Kuricova K, Belobradkova J, Tomandl J, Kankova 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.

  PMID: 26000285 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: intervention group and control group

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: November 1, 2016
• Primary Completion: December 30, 2018
• Study Completion: January 31, 2019
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)