A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients (CRN11)

NYU Langone Hospitals

Status and phase: Completed; Phase 4

Conditions: Pruritis

Treatments: Drug: 50,000 Units Ergocalciferol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01114672

10020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Ergocalciferol

Active Comparator group

Treatment:

Drug: 50,000 Units Ergocalciferol

oral placebo

Placebo Comparator group

Treatment:

Drug: Placebo