THE EFFECT OF VITAMIN D ON THE MICROCIRCULATION OF PATIENTS WITH CHRONIC KIDNEY DISEASE AND VITAMIN D DEFICIENCY - CKD, vitamin D and the microcirculatio

Conditions: Chronic kidney disease and vitamin D deficiency.
MedDRA version: 9.1Level: LLTClassification code 10047626Term: Vitamin D deficiency
MedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney disease

Registration Number: EUCTR2008-008745-38-GB

Lead Sponsor: Barts and the London NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 95

Inclusion Criteria

Inclusion Criteria
1.eGFR between 15 and 60 ml/min/1.73m2
2.Serum 25 (OH) vitamin D levels <70nmol/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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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