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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01548716
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
National Kidney Foundation
Information provided by (Responsible Party):
Mary Schanler, Winthrop University Hospital

Brief Summary:


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.

Condition or disease
Vitamin D Deficiency End Stage Renal Disease

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
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Cross-sectional Analysis of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients
Study Start Date : September 2011
Primary Completion Date : October 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ESRD patients on hemodialysis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01548716

United States, New York
Winthrop University Hospital Dialysis Unit
Mineola, New York, United States, 11023
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
National Kidney Foundation
Principal Investigator: Mary Schanler, RD Winthrop University Hospital

Responsible Party: Mary Schanler, Administrative Dietitian, Winthrop University Hospital Identifier: NCT01548716     History of Changes
Other Study ID Numbers: 11318
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Mary Schanler, Winthrop University Hospital:
Pruritis in hemodialysis patients
25-Vitamin D in chronic kidney disease

Additional relevant MeSH terms:
Kidney Failure, Chronic
Vitamin D Deficiency
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents