Vitamin D, Insulin Resistance, and Cardiovascular Disease

Recruiting

Phase N/A Results N/A

Trial Description

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

Detailed 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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo pill orally daily Calcium carbonate 500 mg twice daily
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
  • Calcium Carbonate Drug
    Intervention Desc: Used medicinally as a calcium supplement or as an antacid.
  • Cholecalciferol Drug
    Other Names: vitamin D3
    Intervention Desc: 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.
  • Vitamin D3 Dietary Supplement
    Other Names: cholecalciferol
    Intervention Desc: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
    ARM 1: Kind: Experimental
    Label: Vitamin D
    Description: Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
  • Cholecalciferol and Calcium Carbonate Drug
    Other Names: Vitamin D
    Intervention Desc: Cholecalciferol 4000 IU daily Calcium carbonate 500mg po bid
    ARM 1: Kind: Experimental
    Label: 2
    Description: Patients in this arm will receive cholecalciferol 4000IU po qday and calcium carbonate 500mg po bid
  • Placebo and Calcium Carbonate Drug
    Other Names: Calcium
    Intervention Desc: Calcium carbonate 500 mg po bid
    ARM 1: Kind: Experimental
    Label: 1
    Description: Placebo group will receive placebo pills in place of vitamin D and calcium carbonate 500 mg po bid

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Hypertension.
Secondary Brachial artery response to hyperemia; systemic inflammatory markers and macrophage inflammatory response to modified-lipoproteins; serum and urinary calcium measurements.
Primary Hypertension 0, 2, and 4 months No
Secondary Brachial artery response to hyperemia 0, 2, and 4 months No
Secondary Systemic inflammatory markers and macrophage inflammatory response to modified-lipoproteins 0 and 4 months No
Secondary Serum and urinary calcium measurements Every two weeks Yes

Sponsors