Vitamin D3 Supplementation in Dialysis Patients

NCT ID: NCT01312714

Last Updated: 2013-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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End-Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cholecalciferol

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

3 tablets of 1000 IU daily for 26 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

3 tablets of 1000 IU daily for 26 weeks

Interventions

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Cholecalciferol

3 tablets of 1000 IU daily for 26 weeks

Intervention Type DRUG

Placebo

3 tablets of 1000 IU daily for 26 weeks

Intervention Type DRUG

Other Intervention Names

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Vitamin D3

Eligibility Criteria

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Inclusion Criteria

* Hemodialysis or peritoneal dialysis \> 3 months

Exclusion Criteria

* Hypercalceamia
* Cancer
* Inability to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regional Hospital Holstebro

OTHER

Sponsor Role lead

Responsible Party

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Erling Bjerregaard Pedersen

DMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erling B Pedersen, M.D., M.Sci.

Role: PRINCIPAL_INVESTIGATOR

Departments of Medical Research and Medicine

Locations

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Departments of Medical Research and Medicine, Holstebro Hospital

Holstebro, Holstebro, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 24661355 (View on PubMed)

Other Identifiers

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EBP-TL-2011

Identifier Type: -

Identifier Source: org_study_id

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