Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Albany College of Pharmacy and Health Sciences
Sponsor:
Collaborators:
Hortense and Louis Rubin Dialysis Centers
Satellite Healthcare
Information provided by (Responsible Party):
Darius Mason, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier:
NCT01312441
First received: March 9, 2011
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency
Renal Failure Chronic Requiring Hemodialysis
Drug: Ergocalciferol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D

Resource links provided by NLM:


Further study details as provided by Albany College of Pharmacy and Health Sciences:

Primary Outcome Measures:
  • The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: January 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ergocalciferol
Ergocalciferol 50,000 IU by mouth once weekly for 6 months
Drug: Ergocalciferol
Ergocalciferol capsules 50,000 IU once weekly for 6 months
Other Name: Drisdol
Placebo Comparator: Placebo
Placebo by mouth once weekly for 6 months
Drug: Placebo
Placebo by mouth once weekly for 6 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01312441

Contacts
Contact: Darius L Mason, Pharm.D. (518) 694-7188 darius.mason@acphs.edu
Contact: Magdalene M Assimon, Pharm.D. (518) 694-7289 magdalene.assimon@acphs.edu

Locations
United States, New York
Stratton VA Medical Center Recruiting
Albany, New York, United States, 12208
Hortense and Louis Rubin Dialysis Center Recruiting
Clifton Park, New York, United States, 12065
Hortense and Louis Rubin Dialysis Center Recruiting
Saratoga Springs, New York, United States, 12866
Hortense and Louis Rubin Dialysis Center Recruiting
Troy, New York, United States, 12180
Sponsors and Collaborators
Albany College of Pharmacy and Health Sciences
Hortense and Louis Rubin Dialysis Centers
Satellite Healthcare
Investigators
Principal Investigator: Darius L Mason, Pharm.D. Albany College of Pharmacy and Health Sciences
Principal Investigator: Roy Mathew, MD Stratton Veteran Affairs Medical Center
  More Information

No publications provided

Responsible Party: Darius Mason, PI, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier: NCT01312441     History of Changes
Other Study ID Numbers: 00741, 10-023
Study First Received: March 9, 2011
Last Updated: November 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Albany College of Pharmacy and Health Sciences:
Vitamin D
Ergocalciferol

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

ClinicalTrials.gov processed this record on November 23, 2014