High-Dose Vitamin D for Preventing Dementia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a high dose of vitamin D (also known as Vitamin D3 or Cholecalciferol) can prevent or slow dementia in older adults. Participants will receive either a high dose or a standard dose of vitamin D to assess its impact on memory and brain health over time. Elderly individuals with low vitamin D levels and some cognitive impairment, such as mild memory issues or early Alzheimer’s, might be suitable for this trial. The goal is to determine if boosting vitamin D can improve brain health, potentially providing a simple method to combat dementia. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings in dementia prevention.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that high doses of vitamin D3, like the 4,000 IU tested in this trial, are generally safe for people. Studies have found that even higher doses, up to 50,000 to 100,000 IU per week, have been safe for up to a year, with no evidence of serious side effects.
Additionally, one study found that medium to high doses of vitamin D3 did not change the risk of dementia in older adults who already had sufficient vitamin D levels. This suggests the high doses were safe, even if they didn't affect dementia rates.
Overall, the data suggest that high-dose vitamin D3 is safe for adults, including older adults. However, monitoring for any side effects and consulting a healthcare provider before starting high-dose vitamin D supplements is always important.12345Why do researchers think this study treatment might be promising?
Most treatments for preventing dementia focus on managing symptoms or slowing progression through medications like cholinesterase inhibitors or memantine. However, this study explores high-dose Vitamin D3, which is unique because it may directly impact brain health by addressing potential vitamin D deficiencies that are linked to cognitive decline. Researchers are excited about high-dose Vitamin D3 because it offers a simple, daily supplement approach that could potentially prevent or delay the onset of dementia. Unlike other treatments, it targets a nutritional angle that could be both preventative and supportive of overall brain health.
What evidence suggests that high-dose vitamin D3 might be an effective treatment for preventing dementia?
This trial will compare the effects of high-dose Vitamin D3 with standard-dose Vitamin D3 in preventing dementia. Research suggests that high doses of Vitamin D3 might lower the risk of dementia. One study found that people who took Vitamin D lived longer without dementia and were less likely to develop it compared to those who didn't take it. Another study showed that a high dose of Vitamin D improved memory in some older adults after 18 weeks. However, not all research agrees, and some studies haven't found a clear benefit for people with Alzheimer's. Overall, high-dose Vitamin D appears promising, but more research is needed to confirm its effects on brain health.23678
Who Is on the Research Team?
John Olichney, MD
Principal Investigator
UC Davis Alzheimer's Disease Center
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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