Ignite Creation Date:
2024-05-05 @ 10:29 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01114672
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2010-04-29
Brief Title:
A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients
Sponsor:
Winthrop University Hospital
Organization:
Winthrop University Hospital
Study Overview
Official Title:
A Randomized Prospective Double-Blind Placebo Controlled Study of Oral Ergocalciferol in the Treatment of Pruritis in Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRN11
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None