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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Placebo; Dietary Supplement: vitamin D3 and calcium

• Registration Number: NCT02464462
• Lead Sponsor: York University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2015-06
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-04
• Last Update Submitted: 2015-06-04
• Study First Posted: 2015-06-08
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	This arm received rice powder pills
CaD Group	vitamin D3 and calcium	This arm received total of 1800 IU of vitamin D3 and 720 mg of calcium

Primary Outcome Measures

Name	Time	Method
Serum calcidiol	3 years

Secondary Outcome Measures

Name	Time	Method
Parathyroid Hormone	3 years
Fasting insulin	3 years
Fasting blood glucose	3 years
Glycated Hemoglobin	3 years