End-Stage Renal Disease
Conditions
Keywords
Hemodialysis, Peritoneal dialysis, Vitamin D Deficiency, blood pressure, arterial stiffness, Heart function, Renin-angiotensin system, Calcium, FGF-23, Brain natriuretic peptide
Brief summary
Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated with cardiovascular risk factors such as increased aortic pulse wave velocity, blood pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect of 26 weeks of vitamin D3 supplementation in patients with end stage renal disease.
Interventions
DRUGCholecalciferol
3 tablets of 1000 IU daily for 26 weeks
DRUGPlacebo
3 tablets of 1000 IU daily for 26 weeks
Sponsors
Regional Hospital Holstebro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hemodialysis or peritoneal dialysis \> 3 months
Exclusion criteria
* Hypercalceamia * Cancer * Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of NT-proBNP | 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of ionized calcium | 4 weeks |
| Plasma concentration of phosphate | 4 weeks |
| Plasma concentration of PTH | 4 weeks |
| Plasma concentration of 25-hydroxycholecalciferol | 4 weeks |
| 24-hour blood pressure | 26 weeks |
| Plasma renin concentration | 26 weeks |
| Plasma concentration of angiotensin II | 26 weeks |
| Plasma concentration of aldosterone | 26 weeks |
| Arterial stiffness | 26 weeks |
| Serum concentration of FGF-23 | 26 weeks |
| Plasma concentration of AVP | 26 weeks |
| Plasma concentration of ANP | 26 weeks |
| Plasma concentration of TNF alpha | 26 weeks |
| Heart Function | 26 weeks |
Countries
Denmark
Outcome results
None listed