Vitamin D Supplementation in Kidney Disease

Completed · Not applicable · Has a placebo group

Conditions studied: Renal Dialysis, Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT01229878

Run by

VA Office of Research and Development

People needed

20

Starts

2011-12-01

Expected to finish

2022-12-30

Last updated by the study team

2025-08-22

Who can join

Age: 45 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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