Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study

This study is currently recruiting participants.
Verified February 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01229878
First received: October 26, 2010
Last updated: February 11, 2014
Last verified: February 2014

October 26, 2010
February 11, 2014
December 2011
June 2014   (final data collection date for primary outcome measure)
Neuromuscular Function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01229878 on ClinicalTrials.gov Archive Site
  • Quality-of-Life self assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Neuropsychological assessments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Immune Function assessments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality-of-Life self assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Neuropsychological assessments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study
Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study

This is a double-blind placebo controlled pilot study to determine if vitamin D supplementation in hemodialysis (HD) patients will improve physical function and cognition. HD patients have a high prevalence of vitamin D deficiency, cognitive impairment, and physical impairment. Despite standard clinical care with active IV vitamin D during dialysis, HD patients still have markedly low levels of nutritional or dietary vitamin D. IV treatment with vitamin D during dialysis is aimed at treating HD related bone disease. Recent literature shows that oral or nutritional vitamin D has multiple extra-skeletal effects including improvement in cognition and physical function. In this study, we plan to administer oral vitamin D to vitamin D deficient HD patients already receiving standard care with IV vitamin D therapy. Patients will be randomized to receive either placebo or 50,000 IU of vitamin D (cholecalciferol) weekly for 6 months. Our specific aims are to 1) Assess the benefits of correcting nutritional vitamin D deficiency on cognitive and physical function in HD patients receiving routine standard of care, 2) Assess the feasibility of recruiting HD patients for this study, and 3) Evaluate the proposed regimen for safely and effectively increasing nutritional vitamin D levels with oral supplementation. We anticipate that correction of nutritional vitamin D deficiency to optimal levels will improve the high prevalence of cognitive impairment and physical impairment in this population. These results will be used as evidence to support a larger study aimed at treating nutritional vitamin D deficiency in all patients receiving HD. These results may also contribute to a change in current guidelines which place little emphasis on the monitoring and treatment of nutritional vitamin D levels in HD patients. These results are important for the veteran dialysis population since many of them are required to perform high-level cognitive tasks such as management of complex medical regimens and physical tasks such as orchestrating independent transportation to and from HD sessions and multiple physician appointments.

Background:

Objectives:

Methods:

Status:

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Renal Dialysis
  • Vitamin D Deficiency
Dietary Supplement: Ergocalciferol (Vitamin D)
50,000 units of ergocalciferol or a placebo pill administered once every 2 weeks for 6 months
  • Active Comparator: Arm 1
    Hemodialysis Patients randomized to take Vitamin D supplements
    Intervention: Dietary Supplement: Ergocalciferol (Vitamin D)
  • Placebo Comparator: Arm 2
    Hemodialysis Patients randomized to take placebo pills
    Intervention: Dietary Supplement: Ergocalciferol (Vitamin D)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Receiving HD for at least two weeks
  • Receiving IV vitamin D supplementation according to National Kidney Foundation guidelines.
  • Male or female with an between the ages of 45-89 years
  • Veteran outpatient or stable community living center patient
  • Able to ambulate independently or with an assistive device for at least 20 feet

Exclusion Criteria:

  • 25-OH vitamin D level < 25 ng/ml
  • Hypercalcemia
  • Active malignancy within 6 months
  • Receiving intravenous antibiotics for infection
  • History of Dementia
  • Hemoglobin < 8.5g
  • History of conditions that interfere with postural instability (e.g. cerebellar disease, vestibular disease or any others that may present)
  • Poor compliance with dialysis treatments (history of skipping 2 treatments per month for > 2 months)
Both
45 Years to 89 Years
No
Contact: Kel G Morin (718) 584-9000 ext 5129 Kel.Morin@va.gov
United States
 
NCT01229878
F7539-P
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: James B. Post, MD VA Medical Center, Bronx
Department of Veterans Affairs
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP