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NCT02464462 Clinical Trial

The Role of Vitamin D3 and Calcium Supplementation in Attenuating T2DM Severity

Type 2 Diabetes Mellitus Clinical Trial

Official title:
The Role of Vitamin D and Calcium Supplementation in the Pathogenesis of Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02464462
Other study ID # 220
Secondary ID STU 2013-024
Status Completed
Phase Phase 1
First received June 3, 2015
Last updated June 4, 2015
Start date May 2010
Est. completion date December 2013

Study information
Verified date June 2015
Source York University
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada and York University Research Ethics Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of vitamin D3 and calcium supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic patiens.

Description:

Subjects of this study received a total of 1800 IU vitamin D3 and 720 mg of calcium per day for 3 years. The study was conducted in Toronto, Ontario, Canada.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date December 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- Type 2 diabetes mellitus

- Non-white, post menopausal female

- Have access to Community Health Center

Exclusion Criteria:

- neurodegenerative disease

- kideny disease

- gluten allergy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• vitamin D3 and calcium
1800 IU vitamin D3 plus 720 mg Calcium
Other:
• Placebo
Rice powder pills

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
York University Women's Health in Women's Hands Community Health Center

Outcome
Type Measure Description Time frame Safety issue
Primary Serum calcidiol 3 years No
Secondary Fasting insulin 3 years No
Secondary Parathyroid Hormone 3 years No
Secondary Fasting blood glucose 3 years No
Secondary Glycated Hemoglobin 3 years No
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