Renal DialysisNCT01229878
Vitamin D Supplementation in Kidney Disease
A study testing Cholecalciferol (Vitamin D) in people with Renal Dialysis and Vitamin D Deficiency, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 89 years
- Conditions the study is for
- Renal Dialysis, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol (Vitamin D)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2011to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Renal Dialysis, Vitamin D Deficiency
- Being tested
- Cholecalciferol (Vitamin D)
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol (Vitamin D)Dietary supplement
50,000 units of cholecalciferol or a placebo pill administered once a week for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Hemodialysis Patients randomized to take Vitamin D supplements Receives: Dietary Supplement: Cholecalciferol (Vitamin D) |
| Placebo | Placebo comparator | Hemodialysis Patients randomized to take placebo pills Receives: Dietary Supplement: Cholecalciferol (Vitamin D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hip Flexor Strength
Neuromuscular Function - strength testing of hip flexors. Hip flexor strength measured using a push-pull muscle strength dynamometer. Participants performed a hip flexor exercise 3 times at each visit. The final result at each time point was an average of the 3 tries. Outcome measure is change between baseline and 6 months.
Measured: 6 months
Secondary outcomes (3)
Quality-of-Life Self Assessment
questionnaire of physical/medical health
Measured: 6 months
Neuropsychological Assessments
battery of neurocognitive tests
Measured: 6 months
Immune Function Assessments
assay of immunity markers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study start1 Dec 2011
- Primary completion30 Jun 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James B Post, MD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229878
- Sponsor's protocol ID
- F7539-P
- Status last verified
- Aug 2025
- First submitted
- 26 Oct 2010
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study
- ClinicalTrials.gov ID
- NCT01229878
- Acronym / sponsor ID
- F7539-P
- Conditions
- Renal Dialysis, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 28 Oct 2010 (estimated)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Dietary Supplement: Cholecalciferol (Vitamin D)Hemodialysis Patients randomized to take Vitamin D supplements |
| Placebo | Placebo comparator | Dietary Supplement: Cholecalciferol (Vitamin D)Hemodialysis Patients randomized to take placebo pills |
Who may qualify
- Ages
- 45 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 25-OH vitamin D level < 25 ng/ml
- Hypercalcemia
- Active malignancy within 6 months
- Receiving intravenous antibiotics for infection
- History of Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecalciferol (Vitamin D)50,000 units of cholecalciferol or a placebo pill administered once a week for 6 months | Dietary supplement | Placebo, Vitamin D |
Primary outcome
Change in Hip Flexor Strength
Time frame: 6 months
Neuromuscular Function - strength testing of hip flexors. Hip flexor strength measured using a push-pull muscle strength dynamometer. Participants performed a hip flexor exercise 3 times at each visit. The final result at each time point was an average of the 3 tries. Outcome measure is change between baseline and 6 months.
3 secondary outcomes
Quality-of-Life Self Assessment
Time frame: 6 months
Neuropsychological Assessments
Time frame: 6 months
Immune Function Assessments
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James B Post, MD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol (Vitamin D) in people with Renal Dialysis and Vitamin D Deficiency, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hip Flexor Strength (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.