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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02005718
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
CKd Patients With Stage 3 and 4 Drug: Cholecalciferol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Cholecalciferol on Endothelial Fucntion and Blood Biomarkers in Patients With Chronic Kidney Disease
Study Start Date : June 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D
Cholecalciferol 300,000 twice
Drug: Cholecalciferol

Primary Outcome Measures :
  1. Flow mediated dilation [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. CD28 null cell frequency [ Time Frame: 16 weeks ]
  2. Blood biomarkers of endothelial function and inflammation [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02005718

Sponsors and Collaborators
St George's, University of London
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Principal Investigator: Debasish Banerjee St Georges

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: St George's, University of London Identifier: NCT02005718     History of Changes
Other Study ID Numbers: 090129
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
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Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents