Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study

• 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 ]

• 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 ]

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.

Background:

Objectives:

Methods:

Status:

• Renal Dialysis
• Vitamin D Deficiency

• Active Comparator: Arm 1
  Hemodialysis Patients randomized to take Vitamin D supplements
  Intervention: Dietary Supplement: Ergocalciferol (Vitamin D)
• Placebo Comparator: Arm 2
  Hemodialysis Patients randomized to take placebo pills
  Intervention: Dietary Supplement: Ergocalciferol (Vitamin D)

Inclusion Criteria:

1. Receiving HD for at least two weeks
2. Receiving IV vitamin D supplementation according to National Kidney Foundation guidelines.
3. Male or female with an between the ages of 45-89 years
4. Veteran outpatient or stable community living center patient
5. Able to ambulate independently or with an assistive device for at least 20 feet

Exclusion Criteria:

1. 25-OH vitamin D level < 25 ng/ml
2. Hypercalcemia
3. Active malignancy within 6 months
4. Receiving intravenous antibiotics for infection
5. History of Dementia
6. Hemoglobin < 8.5g
7. History of conditions that interfere with postural instability (e.g. cerebellar disease, vestibular disease or any others that may present)
8. Poor compliance with dialysis treatments (history of skipping 2 treatments per month for > 2 months)