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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01114672
Other study ID # 10020
Secondary ID
Status Completed
Phase Phase 4
First received April 29, 2010
Last updated February 15, 2013
Start date July 2010
Est. completion date February 2012

Study information

Verified date February 2013
Source Winthrop University Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

Vitamin D2 is a fat soluble steroid hormone precursor which must be hydroxylated in the liver and kidney respectively to make the active form 1-25-Vitamin D. This active metabolite and related analogs have been synthesized and are frequently used in the treatment of hyperparathyroidism in patients with chronic kidney disease. However the active metabolite may not be back metabolized to the precursor forms which may have functions in other organs including the skin. Supplementation of hemodialysis patients with oral vitamin D forms would provide a source of precursors for use throughout the body.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 2012
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

1. Hemodialysis treatment for > 3 months

2. Subjective complaint of excessive itching

Exclusion Criteria:

1. Age < 18 years

2. Failure to provide informed consent

3. Intact PTH < 70 pg/ml or > 1,000 pg/ml

4. Serum phosphorus > 7.0

5. Serum calcium (adjusted for albumin)> 11

6. Active malignancy

7. Likelihood of imminent renal transplantation

8. Current ergocalciferol treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
50,000 Units Ergocalciferol
50,000 Units oral ergocalciferol to be given once weekly
Placebo
oral placebo once weekly

Locations

Country Name City State
United States Winthop Univ Hospital Outpatient Dialysis at Bethpage Bethpage New York
United States Winthrop Univ Hospital Outpatient Dialysis Mineola New York

Sponsors (2)

Lead Sponsor Collaborator
Winthrop University Hospital National Kidney Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
See also
  Status Clinical Trial Phase
Completed NCT04518618 - Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S N/A
Completed NCT00693654 - Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients Phase 4
Completed NCT00323154 - Nalbuphine for the Treatment of Opioid Induced Pruritus in Children Phase 3
Completed NCT03816891 - Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis Phase 2
Recruiting NCT05936567 - Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria Phase 2
Not yet recruiting NCT06226610 - Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic Phase 2
Withdrawn NCT02909569 - Relieving Chronic Itch: Oral Medication Phase 2