Vitamin D, Chronic Kidney Disease (CKD) and the Microcirculation

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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 deficiency.

Hypothesis: Vitamin D therapy in patients with CKD and concomitant vitamin D deficiency will improve endothelial, and therefore microcirculatory function, reduce levels of oxidative stress and thus reduce the risk of future CVS events in this population.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Barts & The London NHS Trust
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. eGFR between 15 and 60 ml/min/1.73m2

2. Serum 25 (OH) vitamin D levels <30nmol/L

3. No evidence of diabetes mellitus (fasting blood sugar <7.1, not taking any diabetic medication)

4. Not receiving haemo or peritoneal dialysis

5. No dialysis therapy within the last 3 months

6. Age > 18 years and < 80 years

7. 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.

8. Able to understand and sign the written Informed Consent Form.

9. Able and willing to follow the Protocol requirements.

Exclusion Criteria:

1. Currently receiving oral ergocalciferol at any dose

2. Received IM ergocalciferol therapy within last 3 months

3. Receiving renal replacement therapy of any type or having recently received any form of dialysis (within 3 months)

4. Pacemaker or any other implanted cardiac device

5. Serum calcium above 2.6 mmol/L at screening

6. Pregnant or lactating

7. Known hypersensitivity to ergocalciferol

8. Patient known to have a condition which predisposes to hypercalcaemia (multiple myeloma, sarcoidosis, other granulomatous disease)

9. Initial blood pressure of >160/100 mmHg

10. History of significant liver disease or cirrhosis

11. Anticipated requirement for dialysis in 6 months

12. Malabsorption, severe chronic diarrhea, or ileostomy

13. Known diagnosis of hypervitaminosis D

14. Known to have diabetes mellitus

15. Known to have renal calculi

16. Known to have systemic sclerosis, Raynaud's phenomenon or other disease associated with known microcirculatory dysfunction

17. Concurrent participation in any other research study

18. Unwilling or unable to complete study protocol