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Vitamin D3 Supplementation in Dialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01312714
First Posted: March 11, 2011
Last Update Posted: May 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
March 9, 2011
March 11, 2011
May 29, 2013
February 2011
September 2012   (Final data collection date for primary outcome measure)
Plasma concentration of NT-proBNP [ Time Frame: 26 weeks ]
Same as current
Complete list of historical versions of study NCT01312714 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Vitamin D3 Supplementation in Dialysis Patients
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
End-Stage Renal Disease
  • Drug: Cholecalciferol
    3 tablets of 1000 IU daily for 26 weeks
    Other Name: Vitamin D3
  • Drug: Placebo
    3 tablets of 1000 IU daily for 26 weeks
  • Active Comparator: Cholecalciferol
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Mose FH, Vase H, Larsen T, Kancir AS, Kosierkiewic R, Jonczy B, Hansen AB, Oczachowska-Kulik AE, Thomsen IM, Bech JN, Pedersen EB. Cardiovascular effects of cholecalciferol treatment in dialysis patients--a randomized controlled trial. BMC Nephrol. 2014 Mar 24;15:50. doi: 10.1186/1471-2369-15-50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
September 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hemodialysis or peritoneal dialysis > 3 months

Exclusion Criteria:

  • Hypercalceamia
  • Cancer
  • Inability to give informed consent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01312714
EBP-TL-2011
Yes
Not Provided
Not Provided
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
Regional Hospital Holstebro
Not Provided
Principal Investigator: Erling B Pedersen, M.D., M.Sci. Departments of Medical Research and Medicine
Regional Hospital Holstebro
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP