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NCT Number: NCT01114672

A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients

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.

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Key information

Conditions

Pruritis Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Winthop Univ Hospital Outpatient Dialysis at Bethpage, Bethpage, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

50,000 Units Ergocalciferol

Drug

50,000 Units oral ergocalciferol to be given once weekly

Placebo

Drug

oral placebo once weekly

Primary outcomes

  1. Severity of Pruritis

    Time frame: Baseline and end of study (up to 12 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Winthrop University Hospital

Other

Collaborators

  • National Kidney Foundation, United States

Registry information

Official study title

A Randomized Prospective, Double-Blind Placebo Controlled Study of Oral Ergocalciferol in the Treatment of Pruritis in Hemodialysis Patients

Acronym: CRN11

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
May 3, 2010
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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