NCT01312714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

1.6 years

First QC Date

March 9, 2011

Last Update Submit

May 28, 2013

Conditions

End-Stage Renal Disease

Keywords

HemodialysisPeritoneal dialysisVitamin D Deficiencyblood pressurearterial stiffnessHeart functionRenin-angiotensin systemCalciumFGF-23Brain natriuretic peptide

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of NT-proBNP

    26 weeks

Secondary Outcomes (14)

  • Plasma concentration of ionized calcium

    4 weeks

  • Plasma concentration of phosphate

    4 weeks

  • Plasma concentration of PTH

    4 weeks

  • Plasma concentration of 25-hydroxycholecalciferol

    4 weeks

  • 24-hour blood pressure

    26 weeks

  • +9 more secondary outcomes

Study Arms (2)

Cholecalciferol

ACTIVE COMPARATOR
Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CholecalciferolDRUG

3 tablets of 1000 IU daily for 26 weeks

Also known as: Vitamin D3
Cholecalciferol
PlaceboDRUG

3 tablets of 1000 IU daily for 26 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemodialysis or peritoneal dialysis \> 3 months

You may not qualify if:

  • Hypercalceamia
  • Cancer
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departments of Medical Research and Medicine, Holstebro Hospital

Holstebro, Holstebro, 7500, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24661355DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Erling B Pedersen, M.D., M.Sci.

    Departments of Medical Research and Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DMSc

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 11, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

DK(1)