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

June 4, 2015 updated by: MAZEN J HAMADEH, York University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CaD Group
This arm received total of 1800 IU of vitamin D3 and 720 mg of calcium
Dietary supplement: vitamin D3 and calcium
1800 IU vitamin D3 plus 720 mg Calcium
Placebo Comparator: Placebo Group
This arm received rice powder pills
Other: Placebo
Rice powder pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum calcidiol
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting insulin
Time Frame: 3 years
3 years
Parathyroid Hormone
Time Frame: 3 years
3 years
Fasting blood glucose
Time Frame: 3 years
3 years
Glycated Hemoglobin
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

York University

Collaborators

Women's Health in Women's Hands Community Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220 (Other Identifier: Greater Manchester Mental Health NHS Foundation Trust)
  • STU 2013-024 (Other Identifier: York University Research Ethics Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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