Role of Vitamin D in heart and kidney Disease
Phase 4
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecified
- Registration Number
- CTRI/2019/10/021494
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Age 18-75 years
2.eGFR by CKD-EPI 15-60 ml/min/1.73m2
3.Serum 25(OH)D levels <20 ng/ml
4.Clinically stable course as judged by the treating physician for last 3 months
Exclusion Criteria
1.Heart failure,
2.present or past malignancy
3.Pregnancy in case of female
4.Vitamin D supplementation within the past 30 days
5.Receiving long-term maintenance dialysis
6.Receiving immunosuppressive therapy
7.Diagnosis of chronic liver disease,
8.Diagnosis of primary hyperparathyroidism
9.Diagnosis of sarcoidosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in immune function parameters at 16 weeks (TH1, TH2,Th17,Treg and CD4+CD28null cells) with cholecalciferol supplementation in patients with Stage 3-4 CKDTimepoint: 16 week
- Secondary Outcome Measures
Name Time Method Change in endothelial function (FMD, e-Selectin, ICAM, VCAM) <br/ ><br>Change in vascular function (PWV) <br/ ><br>Change in inflammatory markers(IFN- γ, TNF-a IL-1β, IL-6, IL-17, IL-23 IL-4, IL-10, and IL-13) <br/ ><br>Timepoint: 16 weeks