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Vitamin D3 Supplementation in Dialysis Patients

Primary Purpose

End-Stage Renal Disease

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
Regional Hospital Holstebro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease focused on measuring Hemodialysis, Peritoneal dialysis, Vitamin D Deficiency, blood pressure, arterial stiffness, Heart function, Renin-angiotensin system, Calcium, FGF-23, Brain natriuretic peptide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hemodialysis or peritoneal dialysis > 3 months

Exclusion Criteria:

  • Hypercalceamia
  • Cancer
  • Inability to give informed consent

Sites / Locations

  • Departments of Medical Research and Medicine, Holstebro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cholecalciferol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Plasma concentration of NT-proBNP

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2011
Last Updated
May 28, 2013
Sponsor
Regional Hospital Holstebro
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1. Study Identification

Unique Protocol Identification Number
NCT01312714
Brief Title
Vitamin D3 Supplementation in Dialysis Patients
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 Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
Hemodialysis, Peritoneal dialysis, Vitamin D Deficiency, blood pressure, arterial stiffness, Heart function, Renin-angiotensin system, Calcium, FGF-23, Brain natriuretic peptide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D3
Intervention Description
3 tablets of 1000 IU daily for 26 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 tablets of 1000 IU daily for 26 weeks
Primary Outcome Measure Information:
Title
Plasma concentration of NT-proBNP
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Plasma concentration of ionized calcium
Time Frame
4 weeks
Title
Plasma concentration of phosphate
Time Frame
4 weeks
Title
Plasma concentration of PTH
Time Frame
4 weeks
Title
Plasma concentration of 25-hydroxycholecalciferol
Time Frame
4 weeks
Title
24-hour blood pressure
Time Frame
26 weeks
Title
Plasma renin concentration
Time Frame
26 weeks
Title
Plasma concentration of angiotensin II
Time Frame
26 weeks
Title
Plasma concentration of aldosterone
Time Frame
26 weeks
Title
Arterial stiffness
Time Frame
26 weeks
Title
Serum concentration of FGF-23
Time Frame
26 weeks
Title
Plasma concentration of AVP
Time Frame
26 weeks
Title
Plasma concentration of ANP
Time Frame
26 weeks
Title
Plasma concentration of TNF alpha
Time Frame
26 weeks
Title
Heart Function
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemodialysis or peritoneal dialysis > 3 months Exclusion Criteria: Hypercalceamia Cancer Inability to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erling B Pedersen, M.D., M.Sci.
Organizational Affiliation
Departments of Medical Research and Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departments of Medical Research and Medicine, Holstebro Hospital
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24661355
Citation
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.
Results Reference
derived

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Vitamin D3 Supplementation in Dialysis Patients

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