Vitamin D, Insulin Resistance, and Cardiovascular Disease

The Washington University

Status: Completed

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

Treatments: Drug: Placebo; Drug: Vitamin D3

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00736632

R01HL094818 (U.S. NIH Grant/Contract)

201103002

Details and patient eligibility

About

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

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Vitamin D

Active Comparator group

Description:

Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.

Treatment:

Drug: Vitamin D3