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High-Dose Vitamin D for Preventing Dementia
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My diagnosis ranges from no cognitive impairment to mild Alzheimer's disease.I have stable heart disease, diabetes, or high blood pressure but still meet other study requirements.I have had kidney stones multiple times.My vitamin D levels are low and I have a history of osteoporosis.You have been diagnosed with Alzheimer's disease based on specific medical guidelines.I have had a serious brain infection or head injury with lasting thinking problems.I have not had cancer in the last 5 years.I regularly use medications for my brain or nerves.I have had several strokes and severe brain changes on MRI.I am between 65 and 90 years old.I am open to taking either a high or standard dose of vitamin D.I am fluent in English or Spanish.I have a history of serious mental health issues.I cannot swallow pills.I have liver or kidney problems.I have mild Alzheimer's with specific cognitive scores and stable treatment for over 6 weeks.I have poor veins for blood tests.I do not have any serious illnesses and my life expectancy is more than 4 years.I am not pregnant and do not plan to become pregnant during the trial.
- Group 1: Standard Dose Vitamin D3
- Group 2: High Dose Vitamin D3
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What adverse reactions have been reported with ingesting high doses of Vitamin D3?
"There is a safety record associated with High Dose Vitamin D3, prompting our team to give it a score of 2 on the scale. This is because the clinical trial lies in Phase 2; meaning there are data backing its safe usage but no evidence that supports its efficacy yet."
Is there an age limit on enrollment for this medical experiment?
"As specified in the admission criteria, patients aged 65 to 90 are eligible for enrollment into this clinical trial."
How many volunteers are participating in this research endeavor?
"Affirmative, according to clinicaltrials.gov the examination is presently in search of participants. This research project was initially posted on March 18th 2019 and last modified May 12th 2022. 180 study volunteers are required from a single site."
Are there any available openings for participants in this clinical research experiment?
"This medical trial is actively recruiting, with its initial posting on March 18th 2019 and the most recent update made on May 12th 2022. This information can be found via clinicaltrials.gov."
What qualifications are necessary to be accepted into this clinical study?
"This trial is recruiting 180 people aged 65 to 90 with Vitamin d deficiency. To be included in the Mild cognitive impairment (MCI) subgroup, participants must have memory scores lower than 1.5 standard deviations below average as well as a minimum Montreal Cognitive Assessment score of 20 or 17 depending on their level of education and a Clinical Dementia Rating global score of 0.5. In order to join the No Cognitive Impairment (NC) group, no cognitive impairment should be present on neuropsychological tests according to consensus diagnosis from investigators at both sites, alongside an MOCA score higher than 23 for those who had"
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