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Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study
This study is currently recruiting participants.
Verified February 2017 by VA Office of Research and Development
Sponsor:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01229878
First received: October 26, 2010
Last updated: February 17, 2017
Last verified: February 2017
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| First Received Date ICMJE | October 26, 2010 | ||||||||
| Last Updated Date | February 17, 2017 | ||||||||
| Actual Start Date ICMJE | December 1, 2011 | ||||||||
| Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Neuromuscular Function [ Time Frame: 6 months ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01229878 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study | ||||||||
| Official Title ICMJE | Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study | ||||||||
| 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. | ||||||||
| Detailed Description | Background: Objectives: Methods: Status: |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Dietary Supplement: Cholecalciferol (Vitamin D)
50,000 units of cholecalciferol or a placebo pill administered once a week for 6 months |
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| Study Arms |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | June 2018 | ||||||||
| Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 45 Years to 89 Years (Adult, Senior) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01229878 | ||||||||
| Other Study ID Numbers ICMJE | F7539-P | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement |
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| Responsible Party | VA Office of Research and Development | ||||||||
| Study Sponsor ICMJE | VA Office of Research and Development | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | VA Office of Research and Development | ||||||||
| Verification Date | February 2017 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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