Vitamin D, Insulin Resistance, and Cardiovascular Disease
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Status:
This study is currently recruiting participants.
Purpose:
To evaluate the effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D deficient hypertensive patients with diabetes.
Interventions:
Calcium Carbonate
Used medicinally as a calcium supplement or as an antacid.
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Cholecalciferol
Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.
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Placebo
A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
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Year Started:
2006
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study.
Inclusion Criteria
Type 2 diabetic with 25 (OH) Vitamin D levels < 20 ng/ml; both genders; all ethnic groups; oral treatment for hyperglycemic; HbA1c between 5.5% -9.5%; recent diagnosis of mild-moderate increase in blood pressure (BP systolic 125-160 BP diastolic 85-100) with or without taking blood pressure medications. we will include patients receiving oral contraceptives or those under treatment for lipid abnormalities with normal liver function tests, normal electrolytes and with a calculated creatinine clearance of 80-140 ml/min. We will also include patients recently diagnosed with microalbuminuria but with no gross proteinuria. Patients with serum calcium levels 8.0 -8.5 mg/dl without clinical manifestations
Exclusion Criteria
Pregnancy; patients with BP systolic >160 or BP diastolic >100 mmHg; urinary calcium-creatinine ratio >0.2; patients with body mass index less than 20 or more 45; heavy alcohol abuse (male > 2 drinks per day and women >1 drink per day);
stage 4 chronic renal failure calculated by MDRD eGFR equation and or >2+ proteinuria on urine dipstick will be excluded.
Patient Involvement:
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.
Primary Outcome:
Hypertension.
Secondary Outcome:
Brachial artery response to hyperemia; systemic inflammatory markers and macrophage inflammatory response to modified-lipoproteins; serum and urinary calcium measurements.
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 11/3/2009
Reviewed on: 05/04/2009.
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