Effect of Vitamin D Supplementation on Glucose Tolerance in Subjects at Risk for Diabetes With Low Vitamin D.
NCT01726777 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71
Last updated 2015-09-17
Summary
Type 2 diabetes (T2D) is an increasingly common and serious condition. Studies show that low vitamin D levels are associated with increased diabetes risk and that vitamin D may protect against diabetes by reducing chronic inflammation and improving insulin sensitivity and insulin secretion. However, no studies have been able to show that vitamin D actually reduces post-prandial blood glucose levels, the most clinically relevant marker of diabetes. Previously the investigators have shown that cheddar cheese and low-fat cheese can be fortified with high levels of vitamin D and that this cheese is at least as a effective as vitamin D supplements in raising blood vitamin D levels.
The main purpose of this study is to see whether vitamin D enriched cheese can improve oral glucose tolerance (reduce blood glucose 2 hours after consuming a drink containing 75g sugar) in people who have low vitamin D levels and are at risk for developing T2D.
Other aims are to determine the effect of vitamin D may on insulin sensitivity, insulin secretion, markers of inflammation, blood cholesterol levels, and safety markers such as urinary calcium excretion.
Conditions
- Type 2 Diabetes Mellitus
- Vitamin D Deficiency
Interventions
- DIETARY_SUPPLEMENT
-
Control
Normal cheddar cheese
- DIETARY_SUPPLEMENT
-
Vitamin D
Vitamin D3 supplemented cheddar cheese
Sponsors & Collaborators
-
Dairy Farmers of Canada
collaborator OTHER -
Public Health Agency of Canada (PHAC)
collaborator OTHER_GOV -
University of Toronto
lead OTHER
Principal Investigators
-
Thomas MS Wolever, DM, PhD · University of Toronto
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2015-09-30
- Completion
- 2015-09-30
Countries
- Canada
Study Locations
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