The Effect of Vitamin D Supplementation on Arterial Stiffness, Blood Pressure, Oxidative Stress and Inflammation in Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- arterial stiffness
Study Overview
Brief Summary
The incidence of type 2 Diabetes Mellitus is increasing at an alarming rate worldwide.
Cardiovascular disease is the leading cause of death in patients with type 2 diabetes.
Recently, increasing amount of evidence suggests that vitamin D may influence various nonskeletal medical conditions, including cardiovascular disease, hypertension, diabetes, cancer, autoimmune disorders and more. The purpose of this trial is to investigate the effect of vitamin D supplementation on 24 hours blood pressure monitoring, arterial stiffness, oxidative stress and inflammation in vitamin D deficient diabetic patients.
Detailed Description
Background:
The incidence of type 2 Diabetes Mellitus is increasing at an alarming rate worldwide, with more than 1 million new cases per year diagnosed in the United States alone. [1] Diabetes is the fifth leading cause of death in the United States, and it is also a major cause of significant morbidity.
Cardiovascular disease is the leading cause of death in patients with type 2 diabetes.
The risk of Cardiovascular disease (CVD) mortality in type 2 diabetic patients is more than double compared with that in age-matched subjects. [2] Therefore, reducing cardiovascular risk in diabetic patients is of great importance.
Vitamin D3 (cholecalciferol), the most powerful form of vitamin D, is synthesized in the skin from 7-dehydrocholesterol by action of sunlight (ultraviolet B radiation). Vitamin D3 is biologically inert. In the hepatic parenchyma, vitamin D3 is converted to 25-hydroxyvitamin D3 (25OHD3) and must be converted to the active hormone 1,25-dihydroxy vitamin D (calcitriol). 25OHD is the most plentiful and stable metabolite of vitamin D. As such, the 25OHD level in the serum is the best indicator of vitamin D level. [3]
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diabetic patients
- •Aged 18 years or older
- •VITAMIN d deficiency
Exclusion Criteria
- •A history of treatment with vitamin D supplementation in the last 3 months
- •Treatment with nitrates
- •Uncontrolled heart failure
- •Uncontrolled hypertension and/or any change in the hypertensive medications during the last 1 month.
- •Any malignancy with life expectancy of less then 1 year
- •Pregnancy
Arms & Interventions
vitamin D
Baby D3 drops
Intervention: Baby D3 drops (Drug)
Outcomes
Primary Outcomes
arterial stiffness
Time Frame: 3 months
Secondary Outcomes
- blood pressure holter(3 months)
Investigators
Fany Tusia
medical center
Assaf-Harofeh Medical Center