High-Dose Vitamin D for Preventing Dementia

Recruiting in Palo Alto (17 mi)

Overseen byJohn Olichney, MD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, Davis

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

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.

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

My diagnosis ranges from no cognitive impairment to mild Alzheimer's disease.

For No Cognitive Impairment (NC) subgroup: No significant cognitive impairment on baseline neuropsychological tests, minimum MOCA score of 23 or above for education >12 y, or MOCA >20 for education <12 y

I am between 65 and 90 years old.

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Exclusion Criteria

Unable to undergo MRI scanning

I have had kidney stones multiple times.

My vitamin D levels are low and I have a history of osteoporosis.

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Treatment Details

Interventions

Vitamin D3 (Vitamin Supplement)

Trial OverviewThe study tests if high-dose Vitamin D3 (4,000 IU daily) can correct insufficiency better than the standard dose (~800 IU daily) in elderly people at risk for dementia. It also examines whether higher doses affect cognitive decline over 3½ years using brain scans and genetic markers related to Vitamin D reception.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: High Dose Vitamin D3Experimental Treatment1 Intervention

Receives 4000 IU daily Vitamin D3 tablets.

Group II: Standard Dose Vitamin D3Active Control1 Intervention

Receives 600 IU Vitamin D3 tablets.

Vitamin D3 is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Cholecalciferol for: