NCT01312714
Completed
Phase 2
A Randomized, Placebo-Controlled, Double Blind Study Evaluating the Effect of Cholecalciferol on Vasoactive Hormones, Heart Function, Arterial Stiffness, and Blood Pressure in Dialysis Patients.
Regional Hospital Holstebro1 site in 1 country64 target enrollmentFebruary 2011
Overview
- Phase
- Phase 2
- Intervention
- Cholecalciferol
- Conditions
- End-Stage Renal Disease
- Sponsor
- Regional Hospital Holstebro
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Plasma concentration of NT-proBNP
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Erling Bjerregaard Pedersen
DMSc
Regional Hospital Holstebro
Eligibility Criteria
Inclusion Criteria
- •Hemodialysis or peritoneal dialysis \> 3 months
Exclusion Criteria
- •Hypercalceamia
- •Inability to give informed consent
Arms & Interventions
Cholecalciferol
Intervention: Cholecalciferol
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Plasma concentration of NT-proBNP
Time Frame: 26 weeks
Secondary Outcomes
- 24-hour blood pressure(26 weeks)
- 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)
- 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)
Study Sites (1)
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