Vitamin D Supplementation in Kidney Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Renal Impairment / Chronic Kidney Disease, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 45 - 89 |
| Updated: | 3/14/2019 |
| Start Date: | December 1, 2011 |
| End Date: | June 30, 2021 |
| Contact: | Kel G Morin |
| Email: | Kel.Morin@va.gov |
| Phone: | (718) 584-9000 |
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.
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.
Patients will first be identified based on the inclusion criteria, then informed about the
study and consented. Those who meet the exclusion criteria will be randomized to treatment or
placebo. Enrolled participants will be randomized 2:1 to receive vitamin D (n=20) or placebo
(n=10) for 6 months. All participants will be tested twice over two weeks to establish
baseline values. Following baseline testing, the treatment group will receive 50,000 IU
(standard replacement therapy) of oral cholecalciferol or placebo. The initial dose of
cholecalciferol will be 50,000 IU weekly for 6 weeks. Vitamin D levels will then be measured.
Participants who still have Vitamin D insufficiency ( 35 ng/ml) will remain on 50,000 IU of
cholecalciferol for another 6 weeks, at which point Vitamin D levels will be measured again.
Participants who reach 25-OH levels > 35 ng/ml will have their dosing regimen lessened to
10,000 IU weekly (maintenance dose) for the remainder of the 6 months. Participants receiving
placebo will start taking the placebo maintenance dose after the first 6 weeks. For safety
monitoring, 25(OH) vitamin D3 levels will also be re-measured at monthly intervals and
followed by an independent medical monitor. In patients who have serum vitamin D levels
60ng/ml, the frequency of administration will be reduced to once a month. The participants
will receive supplementation for a total of 6 months. At this time, vitamin D levels will be
reassessed and participants will undergo follow-up functional assessments, and cognitive and
immune testing.
study and consented. Those who meet the exclusion criteria will be randomized to treatment or
placebo. Enrolled participants will be randomized 2:1 to receive vitamin D (n=20) or placebo
(n=10) for 6 months. All participants will be tested twice over two weeks to establish
baseline values. Following baseline testing, the treatment group will receive 50,000 IU
(standard replacement therapy) of oral cholecalciferol or placebo. The initial dose of
cholecalciferol will be 50,000 IU weekly for 6 weeks. Vitamin D levels will then be measured.
Participants who still have Vitamin D insufficiency ( 35 ng/ml) will remain on 50,000 IU of
cholecalciferol for another 6 weeks, at which point Vitamin D levels will be measured again.
Participants who reach 25-OH levels > 35 ng/ml will have their dosing regimen lessened to
10,000 IU weekly (maintenance dose) for the remainder of the 6 months. Participants receiving
placebo will start taking the placebo maintenance dose after the first 6 weeks. For safety
monitoring, 25(OH) vitamin D3 levels will also be re-measured at monthly intervals and
followed by an independent medical monitor. In patients who have serum vitamin D levels
60ng/ml, the frequency of administration will be reduced to once a month. The participants
will receive supplementation for a total of 6 months. At this time, vitamin D levels will be
reassessed and participants will undergo follow-up functional assessments, and cognitive and
immune testing.
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)
We found this trial at
1
site
Bronx, New York 10468
Principal Investigator: James B Post, MD
Phone: 718-584-9000
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