search
Back to results

Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D

Primary Purpose

Vitamin D Deficiency, Renal Failure Chronic Requiring Hemodialysis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ergocalciferol
Placebo
Sponsored by
Albany College of Pharmacy and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Ergocalciferol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Activated vitamin D administration
  • On chronic hemodialysis for ≥ 6 months
  • Use of a synthetic biocompatible dialysis membrane
  • 25-hydroxyvitamin D levels < 30 ng/mL
  • Corrected serum calcium < 10.2 mg/dL
  • Serum phosphate < 7 mg/dL
  • Iron replete (Ferritin > 200 ng/mL and transferrin saturation > 20%)

Exclusion Criteria:

  • Current participation in any other investigational drug trial
  • Vitamin D deficiency due to a heredity disorder
  • Liver disease or failure
  • Current or past treatment with ergocalciferol or cholecalciferol ≥ 2000 IU per day (within the past 6 months)
  • Treatment with calcimimetics or bisphosphonates within the last 3 months
  • Treatment with anti-epileptics or other medications that can effect vitamin D metabolism
  • Malnutrition (serum albumin < 2.5 mg/dL)
  • Pregnancy, positive pregnancy test or breastfeeding
  • Malignancy or other significant inflammatory disease
  • HIV/AIDS

Sites / Locations

  • Stratton VA Medical Center
  • Hortense and Louis Rubin Dialysis Center
  • Hortense and Louis Rubin Dialysis Center
  • Hortense and Louis Rubin Dialysis Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ergocalciferol

Placebo

Arm Description

Ergocalciferol 50,000 IU by mouth once weekly for 6 months

Placebo by mouth once weekly for 6 months

Outcomes

Primary Outcome Measures

The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol

Secondary Outcome Measures

Full Information

First Posted
March 9, 2011
Last Updated
January 13, 2016
Sponsor
Albany College of Pharmacy and Health Sciences
Collaborators
VA Office of Research and Development, Hortense & Louis Rubin Dialysis Center, Satellite Healthcare
search

1. Study Identification

Unique Protocol Identification Number
NCT01312441
Brief Title
Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D
Official Title
Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany College of Pharmacy and Health Sciences
Collaborators
VA Office of Research and Development, Hortense & Louis Rubin Dialysis Center, Satellite Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The prevalence of vitamin D deficiency increases as kidney function declines. As a result, many hemodialysis patients often have low levels of vitamin D. Recent evidence has shown that vitamin D supplementation may improve many aspects of poor health such as heart disease and inflammatory markers. The objectives of this study are to determine how supplementing dialysis patients with ergocalciferol increases vitamin D levels, how long vitamin D levels can be maintained after a 6 month treatment course, and to examine the effect of ergocalciferol on biomarkers of inflammation and vascular health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Renal Failure Chronic Requiring Hemodialysis
Keywords
Vitamin D, Ergocalciferol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ergocalciferol
Arm Type
Experimental
Arm Description
Ergocalciferol 50,000 IU by mouth once weekly for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo by mouth once weekly for 6 months
Intervention Type
Drug
Intervention Name(s)
Ergocalciferol
Other Intervention Name(s)
Drisdol
Intervention Description
Ergocalciferol capsules 50,000 IU once weekly for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo by mouth once weekly for 6 months
Primary Outcome Measure Information:
Title
The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Activated vitamin D administration On chronic hemodialysis for ≥ 6 months Use of a synthetic biocompatible dialysis membrane 25-hydroxyvitamin D levels < 30 ng/mL Corrected serum calcium < 10.2 mg/dL Serum phosphate < 7 mg/dL Iron replete (Ferritin > 200 ng/mL and transferrin saturation > 20%) Exclusion Criteria: Current participation in any other investigational drug trial Vitamin D deficiency due to a heredity disorder Liver disease or failure Current or past treatment with ergocalciferol or cholecalciferol ≥ 2000 IU per day (within the past 6 months) Treatment with calcimimetics or bisphosphonates within the last 3 months Treatment with anti-epileptics or other medications that can effect vitamin D metabolism Malnutrition (serum albumin < 2.5 mg/dL) Pregnancy, positive pregnancy test or breastfeeding Malignancy or other significant inflammatory disease HIV/AIDS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darius L Mason, Pharm.D.
Organizational Affiliation
Albany College of Pharmacy and Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roy Mathew, MD
Organizational Affiliation
Stratton Veteran Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stratton VA Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Hortense and Louis Rubin Dialysis Center
City
Clifton Park
State/Province
New York
ZIP/Postal Code
12065
Country
United States
Facility Name
Hortense and Louis Rubin Dialysis Center
City
Saratoga Springs
State/Province
New York
ZIP/Postal Code
12866
Country
United States
Facility Name
Hortense and Louis Rubin Dialysis Center
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D

We'll reach out to this number within 24 hrs