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| Name | Class |
|---|---|
| National Kidney Foundation, United States | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ergocalciferol | Active Comparator |
| |
| oral placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50,000 Units Ergocalciferol | Drug | 50,000 Units oral ergocalciferol to be given once weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Fishbane, MD | Department of Nephrology, Winthrop Univ Hospital | Study Director |
| Mary Schanler, MS, RD | Winthrop University Hospital, Outpatient Dialysis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthop Univ Hospital Outpatient Dialysis at Bethpage | Bethpage | New York | 11714 | United States | ||
| Winthrop Univ Hospital Outpatient Dialysis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33283264 | Derived | 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. | |
| 23453391 | Derived | 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. |
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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.
Adult patients undergoing maintenance hemodialysis were recruited from two hemodialysis facilities from 8/11/2010 to 8/1/2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Oral Placebo | Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Oral Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number randomized in each arm 25 | Posted | Mean | Standard Deviation | units on a scale | Baseline and end of study (up to 12 weeks) |
|
15 months
Only serious adverse events were intended to be collected in this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroparesis | Gastrointestinal disorders | Non-systematic Assessment | Patient admitted to hospital with gastroparesis. Determined not to be related to study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Schanler, Principal Investigator | Winthrop University Hospital | 5156639028 | mschanler@winthrop.org |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| Placebo | Drug | oral placebo once weekly |
|
| Mineola |
| New York |
| 11501 |
| United States |
| Lost to Follow-up |
|
| transplanted |
|
Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Oral Placebo |
Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks. |
|
|
| 1 |
| 25 |
| 0 |
| 0 |
| EG001 | Oral Placebo | Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks. | 2 | 25 | 0 | 0 |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment | Not related to study |
|
| Abdominal distension | Hepatobiliary disorders | Non-systematic Assessment | Not related to study |
|
| Cirrhosis | Hepatobiliary disorders | Non-systematic Assessment | Pre-existing condition |
|
| Hepatic Encephalopathy | Hepatobiliary disorders | Non-systematic Assessment | Not related to study |
|
| Death | Hepatobiliary disorders | Non-systematic Assessment | Not related to study |
|
| Hypotension | Cardiac disorders | Non-systematic Assessment | Not related to study |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |