Impact of Vitamin D on Endothelial Function and Blood Biomarkers Including CD28 Null Cells in CKD
Impact of Cholecalciferol on Endothelial Fucntion and Blood Biomarkers in Patients With Chronic Kidney Disease
1 other identifier
interventional
36
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2010
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
December 9, 2013
CompletedDecember 9, 2013
December 1, 2013
3 years
December 3, 2013
December 3, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Flow mediated dilation
16 weeks
Secondary Outcomes (2)
CD28 null cell frequency
16 weeks
Blood biomarkers of endothelial function and inflammation
16 weeks
Study Arms (1)
Vitamin D
EXPERIMENTALCholecalciferol 300,000 twice
Interventions
Eligibility Criteria
You may qualify if:
- CKD 3-4 Age 18-80
You may not qualify if:
- Recent MI, CVA, malignancy active infection active inflammation High calcium already on Viatmin D therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Chitalia N, Ismail T, Tooth L, Boa F, Hampson G, Goldsmith D, Kaski JC, Banerjee D. Impact of vitamin D supplementation on arterial vasomotion, stiffness and endothelial biomarkers in chronic kidney disease patients. PLoS One. 2014 Mar 19;9(3):e91363. doi: 10.1371/journal.pone.0091363. eCollection 2014.
PMID: 24646518DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debasish Banerjee
St Georges
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2013
First Posted
December 9, 2013
Study Start
June 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
December 9, 2013
Record last verified: 2013-12