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Role of Vitamin D in heart and kidney Disease

Mechanistic analysis of the effect of cholecalciferol supplementation on endothelial, smooth muscle and immune function in patients with Chronic kidney Disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021494
Enrollment
65
Registered
2019-10-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: Cholecalciferol: Doses 300000IU Frequency: twice( at day 0 and at week 16) Route: oral Therapy Duration: 8 week Control Intervention1: NA: NA

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years 2. eGFR by CKD-EPI 15-60 ml/min/1.73m2 3. Serum 25(OH)D levels 4. Clinically stable course as judged by the treating physician for last 3 months

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Change in endothelial function (FMD, e-Selectin, ICAM, VCAM) Change in vascular function (PWV) Change in inflammatory markers(IFN- ?, TNF-a IL-1ß, IL-6, IL-17, IL-23 IL-4, IL-10, and IL-13) Timepoint: 16 weeks

Countries

India

Contacts

Public ContactAshok Kumar Yadav

Postgraduate Institute of Medical Education and Research

mails2ashok@gmail.com9914703281

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026