Vitamin D, Insulin Resistance, and Cardiovascular Disease

This study is currently recruiting participants.

Verified August 2012 by Washington University School of Medicine

Sponsor:

Collaborators:

National Heart, Lung, and Blood Institute (NHLBI)

American Diabetes Association

Information provided by (Responsible Party):

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT00736632

First received: August 15, 2008

Last updated: August 1, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 15, 2008

Last Updated Date

August 1, 2012

Start Date ^ICMJE

May 2006

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hypertension [ Time Frame: 0, 2, and 4 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00736632 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Brachial artery response to hyperemia [ Time Frame: 0, 2, and 4 months ] [ Designated as safety issue: No ]
Systemic inflammatory markers and macrophage inflammatory response to modified-lipoproteins [ Time Frame: 0 and 4 months ] [ Designated as safety issue: No ]
Serum and urinary calcium measurements [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Brachial artery response to hyperemia [ Time Frame: 0, 2, and 4 months ] [ Designated as safety issue: No ]
Systemic inflammatory markers and macrophage inflammatory response to modified-lipoproteins [ Time Frame: 0 and 4 months ] [ Designated as safety issue: No ]
Serum and urinary calcium measurements [ Time Frame: Every two weeks ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Vitamin D, Insulin Resistance, and Cardiovascular Disease

Official Title ^ICMJE

Vitamin D, Insulin Resistance, and Cardiovascular Disease

Brief Summary

In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D deficient hypertensive patients with diabetes

Detailed Description

This is a double blinded, placebo controlled trial. Patients who meet the inclusion criteria will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients will be tested for 24h-blood pressure, brachial arterial blood flow, vascular inflammatory markers and macrophage inflammatory response to modified-lipoproteins at baseline, middle and at the end of the study.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Vitamin D Deficiency
Insulin Resistance
Type 2 Diabetes Mellitus
Cardiovascular Disease
Hypertension

Intervention ^ICMJE

Drug: Vitamin D3
Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily

Other Name: Vitamin D
Drug: Placebo
Placebo pill orally daily Calcium carbonate 500 mg twice daily

Study Arm (s)

Placebo Comparator: Placebo
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.

Intervention: Drug: Placebo
Active Comparator: Vitamin D
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.

Intervention: Drug: Vitamin D3

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2015

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 diabetes
25 (OH) vitamin D levels < 25 ng/ml
Age 25 to 80 years
Not on insulin for diabetes treatment
HbA1c 5.5% -9.5%
Mild/moderately increased blood pressure (systolic 120-160, diastolic 80-100) off BP medications

Exclusion Criteria:

Pregnancy
Patients with systolic >160 or diastolic >100 mmHg
High urine calcium or history of recurrent kidney stones
Cardiovascular disease
Stage 3 or worse chronic kidney disease

Gender

Both

Ages

25 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Carlos Bernal-Mizrachi, MD

314-362-0934

cbernal@dom.wustl.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00736632

Other Study ID Numbers ^ICMJE

201103002, R01HL094818

Has Data Monitoring Committee

Yes

Responsible Party

Washington University School of Medicine

Study Sponsor ^ICMJE

Washington University School of Medicine

Collaborators ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)
American Diabetes Association

Investigators ^ICMJE

Principal Investigator:

Carlos Bernal-MIzrachi, M.D.

Washington University School of Medicine

Information Provided By

Washington University School of Medicine

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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