To study effect of Vitamin D supplementation on atherosclerotic risk factors (endothelial dysfunction) in post-renal transplant patients.
Not Applicable
- Conditions
- Health Condition 1: N186- End stage renal disease
- Registration Number
- CTRI/2019/06/019565
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Age group 18-60 years
2.Patients with stable renal functions (serum creatinine <= 1.3 mg/dl) in the post-transplant period ( >6 months)
3.With Vitamin D deficiency ( <30 ng/ml) at baseline.
Exclusion Criteria
1.Patients refusing consent
2.Patients with prior history of atherosclerosis- coronary artery disease/ cerebrovascular accidents
3.Patients with basic disease as diabetes mellitus
4.Patients with past malignancies/ granulomatous infections
5.Patient with history of intake of Vitamin D in the last 30 days
6.Patients with pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effect of vitamin D (Cholecalciferol) supplementation on endothelial function via brachial FMD in renal transplant cases with Vitamin D deficiency versus a placebo-controlled arm.Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method 1. Difference in NMD, CD28 null cells and PWV between the two study arms. <br/ ><br>2. The effect of vitamin D (Cholecalciferol) supplementation in the previously placebo arm (after crossover) on endothelial function (FMD, CD28 null cells and PWV). <br/ ><br> <br/ ><br>Timepoint: 12 weeks <br/ ><br>24 weeks