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Effects of Vitamin D Supplementation on Glucose Metabolism in Women With Former Gestational Diabetes Mellitus

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
RCSI & UCD Malaysia Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy focused on measuring Former gestational Diabetes, Vitamin D deficiency, insulin resistance, beta cell function

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with Gestational Diabetes (GDM) on the most recent pregnancy- between 6 and 48 months post partum at time of recruitment to study
  • Previous GDM defined as-Fasting plasma glucose ≥ 7.0 mmol/l or 2-h plasma glucose ≥ 7.8 mmol/l on 75g OGTT performed during gestation OR As determined by treating physician during index pregnancy
  • With no plan to conceive again within the 6 months of study duration
  • With 75g OGTT at study baseline confirming either Normal respond, Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)
  • Vitamin D deficiency at baseline - defined as Plasma 25-(OH) D concentration of between 15 and 50nmol/L

Exclusion Criteria:

  • Pregnancy or Breast feeding

Sites / Locations

  • Penang Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3

Placebo

Arm Description

Vitamin D3 at 4000 iu per day for 6 months

matching placebo- capsules containing soya oil at 4 capsules a day for 6 months

Outcomes

Primary Outcome Measures

Change in glucose metabolism as assessed by change in Insulin sensitivity index as calculated by HOMA -IR28

Secondary Outcome Measures

Change in Insulin Sensitivity index as calculated by Oral Glucose Insulin Sensitivity Index (OGIS)
Change in plasma 25-OH- Vitamin D level pre and post replacement

Full Information

First Posted
November 12, 2013
Last Updated
November 18, 2013
Sponsor
RCSI & UCD Malaysia Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01992133
Brief Title
Effects of Vitamin D Supplementation on Glucose Metabolism in Women With Former Gestational Diabetes Mellitus
Official Title
The Effects of Vitamin D Supplementation on Blood Glucose and Markers of Metabolic Syndrome in Women With Vitamin D Deficiency and Previous Gestational Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RCSI & UCD Malaysia Campus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gestational Diabetes Mellitus (GDM) and vitamin D deficiency are related to insulin resistance and impaired beta-cell function, with heightened risk for future development of diabetes. The investigators hypothesize that vitamin D supplementation to women with previous gestational diabetes may improve glucose metabolism.
Detailed Description
Gestational diabetes mellitus (GDM) is a state of glucose intolerance occurring during pregnancy and is related to both resistance to peripheral action of insulin and impairment of beta (β)-cell function. Its transient presence during pregnancy alerts to a heightened risk of diabetes in the future. About 10-50% of women with GDM develop diabetes mellitus later on in life. Data from Malaysia found that 50% of GDM women had developed diabetes at an interval of five to seven years post index pregnancy. Therefore, it is paramount that the investigators identify effective measures to prevent diabetes progression in this high-risk group. Vitamin D deficiency has been shown to be associated with insulin resistance and impaired pancreatic function. Vitamin D deficiency is more prevalent in women with GDM and low vitamin D levels correlate with insulin resistance. Interventional studies using vitamin D supplement in an attempt to modify glucose metabolism have yielded mixed results. This may be partly due to variable doses of supplementation used, short duration of follow up and inappropriate target group. A very short duration of less than seven days of supplementation may not be sufficient to demonstrate the potential beneficial effects. Previous studies suggested vitamin D replacement improved glucose metabolism in selected populations only. Benefit was seen in subjects with impaired fasting glucose but not in normal volunteers, nor in patients with established chronic diabetes. It is possible that vitamin D can help with early stage of disturbance in glucose handling, but is unable to augment insulin secretion in subjects with chronic diabetes and exhausted pancreatic function. Lack of adequate dosing may have also accounted for the failure of many previous studies to demonstrate beneficial effects of vitamin D replacement. Adequate vitamin D supplementation would ideally raise blood 25-hydroxyvitamin D (25(OH)D) levels above 80nmol/L because diabetes risk is lowest at this vitamin D level. Supplementation with 4000IU of vitamin D3 per day in a population of South Asian women with proven vitamin D deficiency safely restored the vitamin D level and improved insulin resistance. Very little is known about the relationship between vitamin D status and glucose metabolism in women with former GDM. This study aimed to evaluate the effect of adequate vitamin D supplementation on insulin sensitivity, pancreatic β-cell function and markers of cardio-metabolic risk in Malaysian women with former GDM and vitamin D insufficiency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy, Vitamin D Deficiency
Keywords
Former gestational Diabetes, Vitamin D deficiency, insulin resistance, beta cell function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3
Arm Type
Experimental
Arm Description
Vitamin D3 at 4000 iu per day for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo- capsules containing soya oil at 4 capsules a day for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in glucose metabolism as assessed by change in Insulin sensitivity index as calculated by HOMA -IR28
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Insulin Sensitivity index as calculated by Oral Glucose Insulin Sensitivity Index (OGIS)
Time Frame
6 months
Title
Change in plasma 25-OH- Vitamin D level pre and post replacement
Time Frame
6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with Gestational Diabetes (GDM) on the most recent pregnancy- between 6 and 48 months post partum at time of recruitment to study Previous GDM defined as-Fasting plasma glucose ≥ 7.0 mmol/l or 2-h plasma glucose ≥ 7.8 mmol/l on 75g OGTT performed during gestation OR As determined by treating physician during index pregnancy With no plan to conceive again within the 6 months of study duration With 75g OGTT at study baseline confirming either Normal respond, Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) Vitamin D deficiency at baseline - defined as Plasma 25-(OH) D concentration of between 15 and 50nmol/L Exclusion Criteria: Pregnancy or Breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toh Peng Yeow, MB BCH BAO, FRCP(Edin)
Organizational Affiliation
Penang Medical College, 4 Jalan Sepoy Lines, 11450, Penang, Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penang Medical College
City
Penang
ZIP/Postal Code
11450
Country
Malaysia

12. IPD Sharing Statement

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Effects of Vitamin D Supplementation on Glucose Metabolism in Women With Former Gestational Diabetes Mellitus

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