A Study of 25-hydroxy Vitamin d Levels in Non-itching Hem... | NCT01548716

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

NCT01548716

Sponsor

Winthrop University Hospital

Status

Completed

Last Update Posted

Mar 8, 2012Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Vitamin D Deficiency
End Stage Renal Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Feb 2012Actual

First Submitted Date

Feb 24, 2012

First Submission Date that Met QC Criteria

Mar 5, 2012

First Posted Date

Mar 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2012

Last Update Posted Date

Mar 8, 2012Estimated

Name	Class
National Kidney Foundation, United States	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

ESRD patients on hemodialysis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary Schanler, RD	Winthrop University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Winthrop University Hospital Dialysis Unit		Mineola	New York	11023	United States
Winthrop University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided