Pruritis
Conditions
Keywords
Pruritis in hemodialysis patients, 25-Vitamin D in chronic kidney disease
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.
Interventions
DRUG50,000 Units Ergocalciferol
50,000 Units oral ergocalciferol to be given once weekly
DRUGPlacebo
oral placebo once weekly
Sponsors
National Kidney Foundation, United States
Winthrop University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Pruritis | 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. |
Countries
United States
Participant flow
Recruitment details
Adult patients undergoing maintenance hemodialysis were recruited from two hemodialysis facilities from 8/11/2010 to 8/1/2011.
Pre-assignment details
Three patients failed the screening process due to exclusion criteria: One patient had PTH\<70 pg/mL and two patients had serum phosphorus \>7.0 mg/dL.
Participants by arm
| Arm | Count |
|---|---|
| Ergocalciferol Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks. | 25 |
| Oral Placebo Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | transplanted | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Ergocalciferol | Total | Oral Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 26 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 24 Participants | 13 Participants |
| Age Continuous | 66.1 years STANDARD_DEVIATION 14.7 | 66.2 years STANDARD_DEVIATION 15.6 | 66.2 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 10 Participants | 21 Participants | 11 Participants |
| Sex: Female, Male Male | 15 Participants | 29 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 1 / 25 | 2 / 25 |
Outcome results
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.
Time frame: Baseline and end of study (up to 12 weeks)
Population: Number randomized in each arm 25
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergocalciferol | Severity of Pruritis | Baseline | 10.88 units on a scale | Standard Deviation 5.15 |
| Ergocalciferol | Severity of Pruritis | End of study | 6.64 units on a scale | Standard Deviation 6.14 |
| Oral Placebo | Severity of Pruritis | Baseline | 9.76 units on a scale | Standard Deviation 5.34 |
| Oral Placebo | Severity of Pruritis | End of study | 5.12 units on a scale | Standard Deviation 4.24 |