The Role of Vitamin D3 and Calcium Supplementation in Att... | NCT02464462

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

NCT02464462

Sponsor

York University

Status

Completed

Last Update Posted

Jun 8, 2015Estimated

Enrollment

11Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

vitamin D3 and calcium
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
STU 2013-024	Other Identifier	York University Research Ethics Board

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Aug 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jun 3, 2015

First Submission Date that Met QC Criteria

Jun 4, 2015

First Posted Date

Jun 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2015

Last Update Posted Date

Jun 8, 2015Estimated

Name	Class
Women's Health in Women's Hands Community Health Center	UNKNOWN

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CaD Group	Experimental	This arm received total of 1800 IU of vitamin D3 and 720 mg of calcium	Dietary Supplement: vitamin D3 and calcium
Placebo Group	Placebo Comparator	This arm received rice powder pills	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamin D3 and calcium	Dietary Supplement	1800 IU vitamin D3 plus 720 mg Calcium	CaD Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum calcidiol		3 years

Secondary Outcomes

Measure	Description	Time Frame
Fasting insulin		3 years
Parathyroid Hormone		3 years
Fasting blood glucose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol
D002118	Calcium

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided