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Vitamin D3 Supplementation in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01312714
First received: March 9, 2011
Last updated: May 28, 2013
Last verified: May 2013

March 9, 2011
May 28, 2013
February 2011
September 2012   (final data collection date for primary outcome measure)
Plasma concentration of NT-proBNP [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
  • Plasma concentration of phosphate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Plasma concentration of PTH [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Plasma concentration of 25-hydroxycholecalciferol [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 24-hour blood pressure [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Plasma renin concentration [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of angiotensin II [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of aldosterone [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Arterial stiffness [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Serum concentration of FGF-23 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of AVP [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of ANP [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of TNF alpha [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Heart Function [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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(1):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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01312714
EBP-TL-2011
Yes
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