Study of vitamin D therapy to improve heart function and immune response in patients with chronic kidney disease (CKD)
- Conditions
- eft ventricular hypertrophy (LVH) in patients with non-dialysis dependent chronic kidney disease (CKD stage 3b and 4)Circulatory System
- Registration Number
- ISRCTN47936804
- Lead Sponsor
- Guy's and St. Thomas' NHS Foundation Trust (UK)
- Brief Summary
2019 results in https://doi.org/10.1093/ehjcvp/pvz080 (added 13/12/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. 10g improvement in left ventricular mass (LVM) with oral vitamin D therapy over 1 year<br> 2. Difference in LVM in patients treated with vitamin D compared to controls<br><br> Measured at 52 weeks from enrolment.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Reduction in cardiac fibrosis determined by biomarkers of cardiac fibrosis in serum post vitamin D3 therapy<br> 2. Augmentation of adaptive immune response to Hepatitis B vaccination post oral vitamin D3 supplementation<br> 3. Immune regulation with predominantly antiinflammatory response with oral vitamin D3 therapy<br> 4. Measured at 52 weeks from enrolment.<br>