Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Cholecalciferol: Cholecalciferol 60000 IU once/2 weeks
Route: Oral
Duration: 36 months (feasibility phase 18 months)
Control Intervention1: Placebo: Matching placebo once every 2 weeks
Sponsors
Department of Biotechnology Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 10. Pregnancy in case of females 11. Blood Hemoglobin 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of Major Adverse Cardiovascular Events Feasibility outcome measures will include assessment of the following at end of 18 months: a. percentage of eligible subjects who are recruited b. recruitment rate per month c. percentage of subjects who are withdrawn from study for any reason d. percentage of subjects recruited in first 6 months who complete their scheduled annual follow up visit between 12-18 monthsTimepoint: 3 years Feasibility phase: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will include: a. all-cause mortality b. need for RRT c. change in hsCRP and IL-6 d. change in iPTH, FGF-23, bone specific alkaline phosphatase, and CTX-1 Safety outcome measures will include: a. hypercalcemia requiring temporary or permanent discontinuation of intervention drug b. hypersensitivity reaction after administration of intervention drugTimepoint: 3 years Feasibility phase: 18 months | — |
Countries
India
Contacts
Public ContactVivek Kumar
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed