Vitamin D for heart disease in patients with kidney disease
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecified
- Registration Number
- CTRI/2019/05/019211
- Lead Sponsor
- Department of Biotechnology Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age 18-75 years
2. eGFR by CKD-EPI 10-45 ml/min/1.73m2
3. Serum 25(OH)D levels 20-50 ng/ml
4. Clinically stable course as judged by the treating physician for last 3 months
1. Receiving long-term maintenance dialysis
2. Receiving immunosuppressive therapy
3. Diagnosis of chronic liver disease
4. Diagnosis of primary hyperparathyroidism
5. Diagnosis of sarcoidosis
6. History of having been treated for hypercalcemia due to any cause
7. Anticipated to need long-term renal replacement therapy within 6 months as judged by
treating physician
8. Poor functional status as judged by the treating physician
9. Life expectancy <1 year as judged by the treating physician
10. Pregnancy in case of females
11. Blood Hemoglobin <8 g/dL
12. Serum calcium >9.5 mg/dL
13. History of having received any type of organ transplant
14. Diagnosis of malignancy
15. History of allergy to the interventional drugs (cholecalciferol)
16. Having received vitamin D supplementation in last 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of Major Adverse Cardiovascular Events <br/ ><br> <br/ ><br>Feasibility outcome measures will include assessment of the following at end of 18 months: <br/ ><br>a. percentage of eligible subjects who are recruited <br/ ><br>b. recruitment rate per month <br/ ><br>c. percentage of subjects who are withdrawn from study for any reason <br/ ><br>d. percentage of subjects recruited in first 6 months who complete their scheduled annual follow up visit between 12-18 monthsTimepoint: 3 years <br/ ><br> <br/ ><br>Feasibility phase: 18 months
- Secondary Outcome Measures
Name Time Method Secondary outcome measures will include: <br/ ><br>a. all-cause mortality <br/ ><br>b. need for RRT <br/ ><br>c. change in hsCRP and IL-6 <br/ ><br>d. change in iPTH, FGF-23, bone specific alkaline phosphatase, and CTX-1 <br/ ><br>Safety outcome measures will include: <br/ ><br>a. hypercalcemia requiring temporary or permanent discontinuation of intervention drug <br/ ><br>b. hypersensitivity reaction after administration of intervention drugTimepoint: 3 years <br/ ><br> <br/ ><br>Feasibility phase: 18 months