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ACTIVE NOT RECRUITING
NCT03613116
PHASE2

High-dose Vitamin D Supplements in Older Adults

Sponsor: University of California, Davis

View on ClinicalTrials.gov

Summary

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.

Official title: Phase II RCT of High-dose Vitamin D Supplements in Older Adults

Key Details

Gender

All

Age Range

65 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2019-03-18

Completion Date

2026-12-31

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

One-half of each diagnostic group will be randomized to treatment with high-dose vitamin D3 or to standard dose Vitamin D

Locations (1)

University of California, Davis Alzheimer's Disease Center

Walnut Creek, California, United States