Status:
COMPLETED
Vitamin D, Chronic Kidney Disease (CKD) and the Microcirculation
Lead Sponsor:
Barts & The London NHS Trust
Conditions:
Chronic Kidney Disease
Vitamin D Deficiency
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Overall research aims: This study will examine the effect of vitamin D supplementation on the function of the endothelium and microcirculation of patients with chronic kidney disease and vitamin D def...
Detailed Description
Research rationale: Cardiovascular (CVS) diseases are the major cause of death in patients with chronic kidney disease (CKD), accounting for approximately half of all deaths. Patients with CKD are far...
Eligibility Criteria
Inclusion
- eGFR between 15 and 60 ml/min/1.73m2
- Serum 25 (OH) vitamin D levels \<30nmol/L
- No evidence of diabetes mellitus (fasting blood sugar \<7.1, not taking any diabetic medication)
- Not receiving haemo or peritoneal dialysis
- No dialysis therapy within the last 3 months
- Age \> 18 years and \< 80 years
- Patient agrees not use any medications (prescribed or over-the-counter including herbal remedies) judged to be clinically significant by the Principal Investigator during the course of the study.
- Able to understand and sign the written Informed Consent Form.
- Able and willing to follow the Protocol requirements.
Exclusion
- Currently receiving oral ergocalciferol at any dose
- Received IM ergocalciferol therapy within last 3 months
- Receiving renal replacement therapy of any type or having recently received any form of dialysis (within 3 months)
- Pacemaker or any other implanted cardiac device
- Serum calcium above 2.6 mmol/L at screening
- Pregnant or lactating
- Known hypersensitivity to ergocalciferol
- Patient known to have a condition which predisposes to hypercalcaemia (multiple myeloma, sarcoidosis, other granulomatous disease)
- Initial blood pressure of \>160/100 mmHg
- History of significant liver disease or cirrhosis
- Anticipated requirement for dialysis in 6 months
- Malabsorption, severe chronic diarrhea, or ileostomy
- Known diagnosis of hypervitaminosis D
- Known to have diabetes mellitus
- Known to have renal calculi
- Known to have systemic sclerosis, Raynaud's phenomenon or other disease associated with known microcirculatory dysfunction
- Concurrent participation in any other research study
- Unwilling or unable to complete study protocol
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00882401
Start Date
April 1 2009
End Date
October 1 2010
Last Update
March 22 2011
Active Locations (1)
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1
Barts and the London NHS Trust
London, United Kingdom, E1 1BB