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NCT01548716 Clinical Trial

A Study of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients

Vitamin D Deficiency Clinical Trial

Official title:
A Cross-sectional Analysis of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01548716
Other study ID # 11318
Secondary ID
Status Completed
Phase N/A
First received February 24, 2012
Last updated March 5, 2012
Start date September 2011
Est. completion date February 2012

Study information
Verified date March 2012
Source Winthrop University Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Hypothesis:

25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than those in HD patients with itching

25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of patients complaining of itching.

Description:

25-hydroxy vitamin D levels from non-itching HD patients in this study will be compared to 25-hydroxy vitamin D levels from our ongoing study in HD patients with itching. The primary endpoints for both studies are continuous variables. Student's t test will be used to test for statistical significance. Multiple regression analysis will be used for controlling covariates and testing the interaction among covariates.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date February 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Hemodialysis treatment for > 3 months No complaints of itching within 1 month prior to study enrollment

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Winthrop University Hospital Mineola New York
United States Winthrop University Hospital Dialysis Unit Mineola New York

Sponsors (2)
Lead Sponsor Collaborator
Winthrop University Hospital National Kidney Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 25 hydroxy vitamin D level Pt will have blood sample taken and fill out 1) Pruritis Survey 2) Phosphorus Restriction Compliance Survey up to 2 weeks No
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