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

• Status: Completed
• Trial end date: 2018-10-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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),

• Hypercalcaemia or treatment for a hypercalcaemia,

• Known hypersensitivity to the vitamin D,

• Granulomatous disease,

• Treatment of vit D at doses higher than the current recommendations,

• History of calcium urinary lithiasis of less than 1 year,

• Nonsteroidal antiinflammatory drug (NSAID) chronic treatment,

• Severe medical or surgical affection of less than 3 months,

• Unstable health, severe hepatic or renal deficiency,

• Deprivation of liberty, under judicial protection,

• Institutionalization (EHPAD),

• Illiteracy,

• Participation in another biomedical research. A diagnosis of MCI (Mild Cognitive Impairment) of less than 6 months is not a criterion of non-inclusion.