Vitamin D, Insulin Resistance, and Cardiovascular Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2019-01-13

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pill orally daily Calcium carbonate 500 mg twice daily

Vitamin D

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

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily

Interventions

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Vitamin D3

Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily

Intervention Type DRUG

Placebo

Placebo pill orally daily Calcium carbonate 500 mg twice daily

Intervention Type DRUG

Other Intervention Names

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Vitamin D

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No