Vitamin D, Insulin Resistance, and Cardiovascular Disease
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ClinicalTrials.gov Identifier: NCT00736632 |
Recruitment Status
:
Active, not recruiting
First Posted
: August 18, 2008
Last Update Posted
: February 6, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vitamin D Deficiency Insulin Resistance Type 2 Diabetes Mellitus Cardiovascular Disease Hypertension | Drug: Vitamin D3 Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Vitamin D, Insulin Resistance, and Cardiovascular Disease |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | January 2016 |
Estimated Study Completion Date : | July 2018 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
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Drug: Placebo
Placebo pill orally daily Calcium carbonate 500 mg twice daily
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Active Comparator: Vitamin D
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
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Drug: Vitamin D3
Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
Other Name: Vitamin D
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- Hypertension [ Time Frame: 0, 2, and 4 months ]
- Brachial artery response to hyperemia [ Time Frame: 0, 2, and 4 months ]
- Systemic inflammatory markers and macrophage inflammatory response to modified-lipoproteins [ Time Frame: 0 and 4 months ]
- Serum and urinary calcium measurements [ Time Frame: Monthly ]

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Ages Eligible for Study: | 25 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736632
United States, Missouri | |
Washington Universiy | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Carlos Bernal-MIzrachi, M.D. | Washington University School of Medicine |
Additional Information:
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00736632 History of Changes |
Other Study ID Numbers: |
201103002 R01HL094818 ( U.S. NIH Grant/Contract ) |
First Posted: | August 18, 2008 Key Record Dates |
Last Update Posted: | February 6, 2018 |
Last Verified: | February 2018 |
Keywords provided by Washington University School of Medicine:
Vitamin D Insulin Resistance Type 2 Diabetes Mellitus Cardiovascular Disease |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Cardiovascular Diseases Insulin Resistance Vitamin D Deficiency Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperinsulinism Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Insulin |
Vitamins Vitamin D Ergocalciferols Calcium, Dietary Calcium Carbonate Hypoglycemic Agents Physiological Effects of Drugs Micronutrients Growth Substances Bone Density Conservation Agents Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |