NCT01114672

Brief Summary

Pruritis (itching) is common in many people with chronic renal failure on hemodialysis. There may be many different reasons for the pruritis. Efforts to treat the problem have not been very effective. Vitamin D levels have been found to be low in many hemodialysis patients. Since vitamin D plays an important role in the skin and is effective in treatment of certain skin conditions that involve pruritis, it may have a role in treatment of pruritis in hemodialysis patients. The objective of the investigators study is to determine the effect of supplementation with oral vitamin D2 (ergocalciferol) on pruritis in hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 12, 2013

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

1.3 years

First QC Date

April 29, 2010

Results QC Date

January 8, 2013

Last Update Submit

February 15, 2013

Conditions

Pruritis

Keywords

Pruritis in hemodialysis patients25-Vitamin D in chronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • Severity of Pruritis

    Randomized patients will fill out a survey with questions about the degree and location of their pruritis at baseline and end of study. The total score ranged from 0-21 with 21 being the most severe and zero being the absence of any of the measures of pruritis. Last observation was carried forward to end of study. A decrease in the Severity of Pruritis score over time indicated an improvement in the severity of pruritis.

    Baseline and end of study (up to 12 weeks)

Study Arms (2)

Ergocalciferol

ACTIVE COMPARATOR
Drug: 50,000 Units Ergocalciferol

oral placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

50,000 Units ErgocalciferolDRUG

50,000 Units oral ergocalciferol to be given once weekly

Ergocalciferol
PlaceboDRUG

oral placebo once weekly

oral placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemodialysis treatment for \> 3 months
  • Subjective complaint of excessive itching

You may not qualify if:

  • Age \< 18 years
  • Failure to provide informed consent
  • Intact PTH \< 70 pg/ml or \> 1,000 pg/ml
  • Serum phosphorus \> 7.0
  • Serum calcium (adjusted for albumin)\> 11
  • Active malignancy
  • Likelihood of imminent renal transplantation
  • Current ergocalciferol treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Winthop Univ Hospital Outpatient Dialysis at Bethpage

Bethpage, New York, 11714, United States

Location

Winthrop Univ Hospital Outpatient Dialysis

Mineola, New York, 11501, United States

Location

Related Publications (2)

  • Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.

    PMID: 33283264DERIVED

  • Shirazian S, Schanler M, Shastry S, Dwivedi S, Kumar M, Rice K, Miyawaki N, Ghosh S, Fishbane S. The effect of ergocalciferol on uremic pruritus severity: a randomized controlled trial. J Ren Nutr. 2013 Jul;23(4):308-14. doi: 10.1053/j.jrn.2012.12.007. Epub 2013 Feb 27.

    PMID: 23453391DERIVED

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Mary Schanler, Principal Investigator
Organization
Winthrop University Hospital
mschanler@winthrop.org
5156639028

Study Officials

  • Steven Fishbane, MD

    Department of Nephrology, Winthrop Univ Hospital

    STUDY DIRECTOR

  • Mary Schanler, MS, RD

    Winthrop University Hospital, Outpatient Dialysis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Administrative Dietitian

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 3, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

February 21, 2013

Results First Posted

February 12, 2013

Record last verified: 2013-02

Locations

US(2)