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

NCT ID: NCT02464462

Last Updated: 2015-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CaD Group

This arm received total of 1800 IU of vitamin D3 and 720 mg of calcium

Group Type EXPERIMENTAL

vitamin D3 and calcium

Intervention Type DIETARY_SUPPLEMENT

1800 IU vitamin D3 plus 720 mg Calcium

Placebo Group

This arm received rice powder pills

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Rice powder pills

Interventions

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vitamin D3 and calcium

1800 IU vitamin D3 plus 720 mg Calcium

Intervention Type DIETARY_SUPPLEMENT

Placebo

Rice powder pills

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

York University

OTHER

Sponsor Role lead

Responsible Party

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MAZEN J HAMADEH

Associate Progessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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STU 2013-024

Identifier Type: OTHER

Identifier Source: secondary_id

220

Identifier Type: -

Identifier Source: org_study_id

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