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

This study has been completed.
National Kidney Foundation
Information provided by (Responsible Party):
Mary Schanler, Winthrop University Hospital
ClinicalTrials.gov Identifier:
First received: February 24, 2012
Last updated: March 5, 2012
Last verified: March 2012


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.

Vitamin D Deficiency
End Stage Renal Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Cross-sectional Analysis of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients

Resource links provided by NLM:

Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • 25 hydroxy vitamin D level [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
    Pt will have blood sample taken and fill out 1) Pruritis Survey 2) Phosphorus Restriction Compliance Survey

Enrollment: 50
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mary Schanler, Administrative Dietitian, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01548716     History of Changes
Other Study ID Numbers: 11318
Study First Received: February 24, 2012
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2015