- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01548716
A Study of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients
March 5, 2012 updated by: Mary Schanler, Winthrop University Hospital
A Cross-sectional Analysis of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Mineola, New York, United States, 11501
- Winthrop University Hospital
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Mineola, New York, United States, 11023
- Winthrop University Hospital Dialysis Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
ESRD patients on hemodialysis
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
25 hydroxy vitamin D level
Time Frame: up to 2 weeks
|
Pt will have blood sample taken and fill out 1) Pruritis Survey 2) Phosphorus Restriction Compliance Survey
|
up to 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary Schanler, RD, Winthrop University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
February 24, 2012
First Submitted That Met QC Criteria
March 5, 2012
First Posted (Estimate)
March 8, 2012
Study Record Updates
Last Update Posted (Estimate)
March 8, 2012
Last Update Submitted That Met QC Criteria
March 5, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11318
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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