Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint (D-COG)

Regional University Hospital Center (CHRU)

Status and phase

Completed

Phase 3

Conditions

Memory Disorders

Age-Related Cognitive Decline

Treatments

Drug: Cholecalciferol 100 000 UI

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02185222

2013-005110-36 (EudraCT Number)

SERC12-TC / D-COG

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.