CompletedPhase 3

Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint

France68 participantsStarted 2014-10-23

Plain-language summary

As recommended allowance of oral vitamine D are unable to ensure the recommended serum concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3 higher than the recommended allowance may slow the cognitive decline of patients with a memory complaint.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Pre-Inclusion Criteria : * Patients aged 60 years or older, * Who report to a memory centre with symptoms of memory complaint, * Having a Mini-Mental State Examination (MMSE) score strictly \> the 5th percentile for sociocultural level of the patient (GRECO standards for elderly patients), * Having visual, hearing abilities (authorized equipment) and an oral or written expression sufficient for the suitable realization of the tests, * Who accept participation in the study and are able to sign the informed consent of the - Affiliated to the French social security system. Inclusion Criteria: * Insufficient 25 OH D serum level : 25 OH D \< 50 nmol/L (20 ng/ml), * Normal corrected plasma calcium concentration, * Normal kidney function (cockcroft \> 30 mL/mn) Exclusion Criteria: * Alzheimer's disease or other dementia, * Parkinson's disease treated, * Epilepsy treated, * Huntington's disease, * Brain tumor, * History of a progressive disease which may have consequences for the central nervous system (blood pressure, higher or equal to 180/100 mmHg, chronic pulmonary disease with hypoxia; cerebrovascular accident of less than 3 months, cranial traumatism with persistent neurologic deficit, subdural hematoma, brain surgery), * Antecedent of alcoholism or chronic drug-addiction with an obvious or documented consequence on cognition, * Severe depression : score Montgomery Asberg Depression Rating Scale (MADRS) \> 18, * Psychotropic drug therapy (at the discretion of the clinician…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes from baseline memory functions measured by the score of the total recall test from Free and Cued Selective Recall Reminding Test (Rappel Libre / Rappel Indicé 16 items : RL/RI 16) at one year and at two years

Timeframe: Baseline (at inclusion), one year and two years

Trial details

NCT IDNCT02185222

SponsorUniversity Hospital, Tours

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-10

View on ClinicalTrials.gov More Memory Disorders trials

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.