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

This study has been completed.
Sponsor:
Collaborator:
National Kidney Foundation
Information provided by (Responsible Party):
Mary Schanler, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01548716
First received: February 24, 2012
Last updated: March 5, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
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:

Drug Information available for: Vitamin D
U.S. FDA Resources

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.

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548716

Locations
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Winthrop University Hospital Dialysis Unit
Mineola, New York, United States, 11023
Sponsors and Collaborators
Winthrop University Hospital
National Kidney Foundation
Investigators
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 Diseases
Kidney Failure, Chronic
Vitamin D Deficiency
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Avitaminosis
Deficiency Diseases
Malnutrition
 Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013