Impact of vitamin D supplementation on left ventricular mass on cardiac magnetic resonance imaging and immune regulation in chronic kidney disease: a randomised placebo-controlled trial

Guy's and St. Thomas' NHS Foundation Trust (UK)0 个研究点目标入组 48 人开始时间: 2011年4月5日最近更新: 2020年1月6日

适应症

试验速览

•1. Patients aged 18 - 75 years with CKD stage 3b-4
•2. Documented 25 hydroxy vitamin D defeciency/insufficiency with serum 25 (OH)D levels between 12.5 to 75 nmol/L
•3. Left ventricular mass index (LVMI) between 80 - 160 g/m2 for females and 100 - 160 g/m2 for males
•4. Patients on angiotensin converting enzyme inhibitors and/or angiotensin II receptor blockers

•1. Presence of diabetes mellitus (type I and II)
•2. Serum calcium greater than 2.55 mmol/L
•3. Anaemia (Hb less than 10.0 g/dL or taking regular erythropoiesis stimulating agents)
•4. Known malignancy
•5. History of congestive cardiac failure or ejection fraction less than 40% on ECHO and/or plasma NT-proBNP greater than 500 pg/ml
•6. Uncontrolled hypertension (blood pressure [BP] greater than 150/90 mmHg despite anti-hypertensive medication)
•7. Significant valvular heart disease identified on transthoracic ECHO
•8 Conditions that may influence collagen metabolism such as recent (less than 6 months) surgery or trauma, fibrotic diseases or active inflammatory conditions
•9. Immunosuppressive medications
•10. Presence of arterio-venous fistula for dialysis access
•11. History of previous myocardial infarction (Trop T greater than 0.5)

发起方

Guy's and St. Thomas' NHS Foundation Trust (UK)