Vitamin D3 Supplementation in Dialysis Patients

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2012

Interventions

  • Drug: Cholecalciferol
    • 3 tablets of 1000 IU daily for 26 weeks
  • Drug: Placebo
    • 3 tablets of 1000 IU daily for 26 weeks

Arms, Groups and Cohorts

  • Active Comparator: Cholecalciferol
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Plasma concentration of NT-proBNP
    • Time Frame: 26 weeks

Secondary Measures

  • Plasma concentration of ionized calcium
    • Time Frame: 4 weeks
  • Plasma concentration of phosphate
    • Time Frame: 4 weeks
  • Plasma concentration of PTH
    • Time Frame: 4 weeks
  • Plasma concentration of 25-hydroxycholecalciferol
    • Time Frame: 4 weeks
  • 24-hour blood pressure
    • Time Frame: 26 weeks
  • Plasma renin concentration
    • Time Frame: 26 weeks
  • Plasma concentration of angiotensin II
    • Time Frame: 26 weeks
  • Plasma concentration of aldosterone
    • Time Frame: 26 weeks
  • Arterial stiffness
    • Time Frame: 26 weeks
  • Serum concentration of FGF-23
    • Time Frame: 26 weeks
  • Plasma concentration of AVP
    • Time Frame: 26 weeks
  • Plasma concentration of ANP
    • Time Frame: 26 weeks
  • Plasma concentration of TNF alpha
    • Time Frame: 26 weeks
  • Heart Function
    • Time Frame: 26 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Hemodialysis or peritoneal dialysis > 3 months Exclusion Criteria:

  • Hypercalceamia – Cancer – Inability to give informed consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regional Hospital Holstebro
  • Provider of Information About this Clinical Study
    • Principal Investigator: Erling Bjerregaard Pedersen, DMSc – Regional Hospital Holstebro
  • Overall Official(s)
    • Erling B Pedersen, M.D., M.Sci., Principal Investigator, Departments of Medical Research and Medicine

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