Vitamin D Supplementation in Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01229878
Recruitment Status : Recruiting
First Posted : October 28, 2010
Last Update Posted : March 6, 2018
Information provided by (Responsible Party):
VA Office of Research and Development

October 26, 2010
October 28, 2010
March 6, 2018
December 1, 2011
January 1, 2019   (Final data collection date for primary outcome measure)
Neuromuscular Function [ Time Frame: 6 months ]
strength testing of hip flexors and extensors
Neuromuscular Function [ Time Frame: 6 months ]
Complete list of historical versions of study NCT01229878 on Archive Site
  • Quality-of-Life self assessment [ Time Frame: 6 months ]
    questionnaire of physical/medical health
  • Neuropsychological assessments [ Time Frame: 6 months ]
    battery of neurocognitive tests
  • Immune Function assessments [ Time Frame: 6 months ]
    assay of immunity markers
  • Quality-of-Life self assessment [ Time Frame: 6 months ]
  • Neuropsychological assessments [ Time Frame: 6 months ]
Not Provided
Not Provided
Vitamin D Supplementation in Kidney Disease
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, 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.





Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Renal Dialysis
  • Vitamin D Deficiency
Dietary Supplement: Cholecalciferol (Vitamin D)
50,000 units of cholecalciferol or a placebo pill administered once a week for 6 months
  • Active Comparator: Arm 1
    Hemodialysis Patients randomized to take Vitamin D supplements
    Intervention: Dietary Supplement: Cholecalciferol (Vitamin D)
  • Placebo Comparator: Arm 2
    Hemodialysis Patients randomized to take placebo pills
    Intervention: Dietary Supplement: Cholecalciferol (Vitamin D)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 30, 2019
January 1, 2019   (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)
Sexes Eligible for Study: All
45 Years to 89 Years   (Adult, Senior)
Contact: Kel G Morin (718) 584-9000 ext 5129
Contact: James B Post, MD (718) 584-9000 ext 6635
United States
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
Plan to Share IPD: Undecided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: James B Post, MD VA Office of Research and Development
VA Office of Research and Development
March 2018

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