Clinical trial NCT01114672: A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients
Official title: A Randomized Prospective, Double-Blind Placebo Controlled Study of Oral Ergocalciferol in the Treatment of Pruritis in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pruritis
Keywords: Pruritis in hemodialysis patients
25-Vitamin D in chronic kidney disease
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
Collaborators: name: National Kidney Foundation, United States
First posted: 2010-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Severity of Pruritis
timeFrame: Baseline and end of study (up to 12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Bethpage
country: United States
facility: Winthop Univ Hospital Outpatient Dialysis at Bethpage
state: New York
city: Mineola
country: United States
facility: Winthrop Univ Hospital Outpatient Dialysis
state: New York
Study officials:
affiliation: Department of Nephrology, Winthrop Univ Hospital
name: Steven Fishbane, MD
role: STUDY_DIRECTOR
affiliation: Winthrop University Hospital, Outpatient Dialysis
name: Mary Schanler, MS, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.