Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Renal Dialysis
Vitamin D Deficiency
Dietary Supplement: Cholecalciferol (Vitamin D)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Neuromuscular Function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Hemodialysis Patients randomized to take Vitamin D supplements
Dietary Supplement: Cholecalciferol (Vitamin D)
50,000 units of cholecalciferol or a placebo pill administered once a week for 6 months
Placebo Comparator: Arm 2
Hemodialysis Patients randomized to take placebo pills
Dietary Supplement: Cholecalciferol (Vitamin D)
50,000 units of cholecalciferol or a placebo pill administered once a week for 6 months

Detailed Description:

Background:

Objectives:

Methods:

Status:

  Eligibility

Ages Eligible for Study:   45 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT01229878

Contacts
Contact: Kel G Morin (718) 584-9000 ext 5129 Kel.Morin@va.gov

Locations
United States, New York
VA Medical Center, Bronx Recruiting
Bronx, New York, United States, 10468
Contact: Kel G Morin    718-584-9000 ext 5129    Kel.Morin@va.gov   
Principal Investigator: James B Post, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: James B Post, MD VA Medical Center, Bronx
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01229878     History of Changes
Other Study ID Numbers: F7539-P
Study First Received: October 26, 2010
Last Updated: July 15, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014