High-Dose Vitamin D for Preventing Dementia
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that stable doses of certain medications like SSRIs or SNRIs are allowed. If you are taking vitamin D supplements, you should continue with the same dose throughout the study.
What data supports the effectiveness of the drug Vitamin D3 in preventing dementia?
Is high-dose Vitamin D generally safe for humans?
How does high-dose Vitamin D3 differ from other treatments for preventing dementia?
High-dose Vitamin D3 is unique because it is being studied for its potential neuroprotective effects, possibly through mechanisms like vasoprotection and amyloid clearance, which are not typical of standard dementia treatments. Unlike other treatments, it focuses on addressing vitamin D deficiency, which has been linked to cognitive decline and dementia risk.15678
What is the purpose of this trial?
This Phase II randomized clinical trial aims to test if supplementation with high dose oral vitamin D will successfully correct vitamin D insufficiency, compared to treatment with standard (RDA) dose vitamin D in a diverse community-based elderly cohort. The effect of high-dose vs. standard-dose vitamin D on altering cognitive trajectories will also be assessed and data will be expected to be used in designing a potential definitive Phase III trial in elderly groups at risk for dementia. A total of 180 elderly persons with longitudinal biomarkers, neuropsychological testing and brain MRI scans will be enrolled, with 152 (\~50 with MCI, 50 with mild AD and 50 with no cognitive impairment) expected to complete the 3½-year study. One-half of each diagnostic group will be randomized to treatment with high-dose vitamin D3 (4,000 IU daily) or to standard dose Vitamin D (600 IU capsule daily + \~200 IU dietary = \~800 IU total/day). Longitudinal MRI analyses will provide an estimate of the treatment effect size on brain atrophy rate. Vitamin D receptor genotype polymorphisms and their impact on response to oral supplementation will also be examined. If vitamin D supplementation improves cognitive outcome, this could have a large impact on the public health, since low vitamin D status is a common, readably treatable condition which may provide a novel window to prevent dementia and AD. Furthermore, the higher prevalence of AD and dementia in African Americans and Latinos could be partially attributable to vitamin D insufficiency.
Research Team
John Olichney, MD
Principal Investigator
UC Davis Alzheimer's Disease Center
Eligibility Criteria
This trial is for older adults aged 65-90 with low vitamin D levels and varying degrees of cognitive function, from no impairment to mild Alzheimer's disease. Participants must have a certain score on a cognitive test (MOCA), be fluent in English or Spanish, and willing to take high-dose or standard vitamin D. Exclusions include severe vision/hearing issues, MRI incompatibility, chronic psychiatric illness, substance abuse history, pregnancy plans during the trial, and certain medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants are enrolled and randomized to high-dose or standard-dose Vitamin D treatment
Treatment
Participants receive either high-dose or standard-dose Vitamin D supplementation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Vitamin D3
Vitamin D3 is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
National Institutes of Health (NIH)
Collaborator