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

Barts and the London NHS Trust0 个研究点目标入组 95 人开始时间: 2009年4月16日最近更新: 2012年3月19日

试验速览

暂无简介。

•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
•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

发起方

Barts and the London NHS Trust