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Vitamin D3 Supplementation in Dialysis Patients

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.
ClinicalTrials.gov Identifier: NCT01312714
Recruitment Status : Completed
First Posted : March 11, 2011
Last Update Posted : May 29, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Drug: Cholecalciferol Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : February 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Plasma concentration of NT-proBNP [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Plasma concentration of ionized calcium [ Time Frame: 4 weeks ]
  2. Plasma concentration of phosphate [ Time Frame: 4 weeks ]
  3. Plasma concentration of PTH [ Time Frame: 4 weeks ]
  4. Plasma concentration of 25-hydroxycholecalciferol [ Time Frame: 4 weeks ]
  5. 24-hour blood pressure [ Time Frame: 26 weeks ]
  6. Plasma renin concentration [ Time Frame: 26 weeks ]
  7. Plasma concentration of angiotensin II [ Time Frame: 26 weeks ]
  8. Plasma concentration of aldosterone [ Time Frame: 26 weeks ]
  9. Arterial stiffness [ Time Frame: 26 weeks ]
  10. Serum concentration of FGF-23 [ Time Frame: 26 weeks ]
  11. Plasma concentration of AVP [ Time Frame: 26 weeks ]
  12. Plasma concentration of ANP [ Time Frame: 26 weeks ]
  13. Plasma concentration of TNF alpha [ Time Frame: 26 weeks ]
  14. Heart Function [ Time Frame: 26 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hemodialysis or peritoneal dialysis > 3 months

Exclusion Criteria:

  • Hypercalceamia
  • Cancer
  • Inability to give informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312714

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

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
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by Erling Bjerregaard Pedersen, Regional Hospital Holstebro:
Peritoneal dialysis
Vitamin D Deficiency
blood pressure
arterial stiffness
Heart function
Renin-angiotensin system
Brain natriuretic peptide

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