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
  Purpose

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.


Condition Intervention Phase
End-Stage Renal Disease
Drug: Cholecalciferol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Plasma concentration of NT-proBNP [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cholecalciferol Drug: Cholecalciferol
3 tablets of 1000 IU daily for 26 weeks
Other Name: Vitamin D3
Placebo Comparator: Placebo Drug: Placebo
3 tablets of 1000 IU daily for 26 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemodialysis or peritoneal dialysis > 3 months

Exclusion Criteria:

  • Hypercalceamia
  • Cancer
  • Inability to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312714

Locations
Denmark
Departments of Medical Research and Medicine, Holstebro Hospital
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Principal Investigator: Erling B Pedersen, M.D., M.Sci. Departments of Medical Research and Medicine
  More Information

No publications provided by Regional Hospital Holstebro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erling Bjerregaard Pedersen, DMSc, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01312714     History of Changes
Other Study ID Numbers: EBP-TL-2011
Study First Received: March 9, 2011
Last Updated: May 28, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Regional Hospital Holstebro:
Hemodialysis
Peritoneal dialysis
Vitamin D Deficiency
blood pressure
arterial stiffness
Heart function
Renin-angiotensin system
Calcium
FGF-23
Brain natriuretic peptide

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vitamin D
Ergocalciferols
Vitamins
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014