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Vitamin Supplement

High-Dose Vitamin D for Preventing Dementia

Phase 2
Waitlist Available
Led By John Olichney, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A consensus clinical diagnosis of No Cognitive Impairment, Mild Cognitive Impairment, or mild AD dementia
Age 65-90
Must not have
History of chronic psychiatric illness, major depression, suicide attempts, or suicidal ideation
History of recurrent renal stones
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if high doses of vitamin D can correct vitamin D insufficiency and prevent dementia better than the standard recommended dose.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include hypercalcemia (high calcium levels), kidney stones due to increased calcium absorption with high doses of Vitamin D3. Regular monitoring will help manage any risks associated with these supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis ranges from no cognitive impairment to mild Alzheimer's disease.
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I am between 65 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of serious mental health issues.
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I have had kidney stones multiple times.
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I have had a serious brain infection or head injury with lasting thinking problems.
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I have not had cancer in the last 5 years.
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I regularly use medications for my brain or nerves.
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I have had several strokes and severe brain changes on MRI.
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I cannot swallow pills.
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I have liver or kidney problems.
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I have poor veins for blood tests.
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I do not have any serious illnesses and my life expectancy is more than 4 years.
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I am not pregnant and do not plan to become pregnant during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Correction of VitD insufficiency
SENAS Executive Function Composite Score
Secondary study objectives
Evaluate effect of VitD on Cognitive Change

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D3
2011
Completed Phase 4
~3590

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,793 Previous Clinical Trials
28,191,937 Total Patients Enrolled
4 Trials studying Vitamin D Deficiency
1,087 Patients Enrolled for Vitamin D Deficiency
University of California, DavisLead Sponsor
945 Previous Clinical Trials
4,755,960 Total Patients Enrolled
1 Trials studying Vitamin D Deficiency
60 Patients Enrolled for Vitamin D Deficiency
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,166,376 Total Patients Enrolled
3 Trials studying Vitamin D Deficiency
802 Patients Enrolled for Vitamin D Deficiency
John Olichney, MDPrincipal InvestigatorUC Davis Alzheimer's Disease Center
1 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Vitamin D3 (Vitamin Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03613116 — Phase 2
Vitamin D Deficiency Research Study Groups: Standard Dose Vitamin D3, High Dose Vitamin D3
Vitamin D Deficiency Clinical Trial 2023: Vitamin D3 Highlights & Side Effects. Trial Name: NCT03613116 — Phase 2
Vitamin D3 (Vitamin Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03613116 — Phase 2
Vitamin D Deficiency Patient Testimony for trial: Trial Name: NCT03613116 — Phase 2
~0 spots leftby Dec 2024
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