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Vitamin D Supplementation in Kidney Disease

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ClinicalTrials.gov Identifier: NCT01229878
Recruitment Status : Recruiting
First Posted : October 28, 2010
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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, the investigators 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. The investigators' 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. The investigators 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 or disease Intervention/treatment
Renal Dialysis Vitamin D Deficiency Dietary Supplement: Cholecalciferol (Vitamin D)

Detailed Description:

Background:

Objectives:

Methods:

Status:


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study
Actual Study Start Date : December 1, 2011
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Neuromuscular Function [ Time Frame: 6 months ]
    strength testing of hip flexors and extensors


Secondary Outcome Measures :
  1. Quality-of-Life self assessment [ Time Frame: 6 months ]
    questionnaire of physical/medical health

  2. Neuropsychological assessments [ Time Frame: 6 months ]
    battery of neurocognitive tests

  3. Immune Function assessments [ Time Frame: 6 months ]
    assay of immunity markers


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229878


Contacts
Contact: Kel G Morin (718) 584-9000 ext 5129 Kel.Morin@va.gov
Contact: James B Post, MD (718) 584-9000 ext 6635 james.post@va.gov

Locations
United States, New York
James J. Peters VA Medical Center, Bronx, NY Recruiting
The 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
VA Office of Research and Development
Investigators
Principal Investigator: James B Post, MD VA Office of Research and Development
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01229878     History of Changes
Other Study ID Numbers: F7539-P
First Posted: October 28, 2010    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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
Bone Density Conservation Agents