Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint (NCT02185222) | Clinical Trial Compass
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 range60 Years
SexALL
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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…