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Vitamin D, Insulin Resistance, and Cardiovascular Disease

NCT00736632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2020-02-10

Study results available
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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

Conditions

Interventions

DRUG

Vitamin D3

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

DRUG

Placebo

Placebo pill orally daily Calcium carbonate 500 mg twice daily

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • American Diabetes Association

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Carlos Bernal-MIzrachi, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2019-01-13
Completion
2019-01-13

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00736632 on ClinicalTrials.gov