Impact of Vitamin D on Endothelial Function and Blood Biomarkers Including CD28 Null Cells in CKD

Phase 3

Completed

• Conditions: CKd Patients With Stage 3 and 4
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT02005718
• Lead Sponsor: St George's, University of London

Brief Summary

Vitamin D deficiency is common in CKD and assciated with CV complications. Endothelial dysfucntion is common in CKD and is a harbinger of atherosclerosis. The study investigated the impact of Vitamin D on endothelial fucntion and blood biomarkers in CKD.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-12
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Last Update Submitted: 2013-12-03
• Study First Posted: 2013-12-09
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• CKD 3-4 Age 18-80

Exclusion Criteria

• Recent MI, CVA, malignancy active infection active inflammation High calcium already on Viatmin D therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D	Cholecalciferol	Cholecalciferol 300,000 twice

Primary Outcome Measures

Name	Time	Method
Flow mediated dilation	16 weeks

Secondary Outcome Measures

Name	Time	Method
CD28 null cell frequency	16 weeks
Blood biomarkers of endothelial function and inflammation	16 weeks