Age-Related Cognitive Decline, Memory Disorders
Conditions
Keywords
Vitamin D, Cholecalciferol, 25-hydroxyvitamin D, Memory complaint, Subjective memory complaint, Mild cognitive impairment, Preventive therapy, Cognitive disorders
Brief 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.
Interventions
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
DRUGPlacebo
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (at inclusion), one year and two years | The score of the total recall test from Free and Cued Selective Recall Reminding Test (RL/RI 16) is recommended by a European Task Force consensus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years | Baseline (inclusion), one year and two years | — |
| Evolution of anaemia evaluated by red blood cells count | Baseline (pre-inclusion), one year and two years | — |
| Evolution of plasma calcium and albumin concentration | Baseline (pre-inclusion), 45 days, one year and two years | — |
| Evolution of urinary calcium and creatinine concentration | 45 days, one year and two years | — |
| All adverse events | Up to two years | — |
| Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance | Baseline (pre-inclusion), one year and two years | — |
| Changes from baseline global efficiency measured by the Mini Mental State Examination at one year and at two years | Baseline (at inclusion), one year and two years | — |
| Changes from baseline global efficiency measured by the Montreal Cognitive Assessment at one year and at two years | Baseline (at inclusion), one year and two years | — |
| Changes from baseline instrumental activity of daily living measured by 8 items at one year and at two years | Baseline (at inclusion), one year and two years | — |
| Changes from baseline attention and speed processing measured by the Digit symbol test at one year and at two years | Baseline (at inclusion), one year and two years | — |
| Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48) | Baseline at inclusion | — |
| Changes from baseline executive functions measured by the stroop test at one year and at two years | Baseline (at inclusion), one year and two years | — |
| Changes from baseline executive functions measured by the verbal fluency at one year and at two years | Baseline (at inclusion), one year and two years | — |
| Changes from baseline executive functions measured by the Trail Making Test part B at one year and at two years | Baseline (at inclusion), one year and two years | — |
| Changes from baseline attention and speed processing measured by the Trail Making Test part A at one year and at two years | Baseline (at inclusion), one year and two years | — |
| Changes from baseline visuospatial study measured by the Rey figure (copy) at one year and at two years | Baseline (at inclusion), one year and two years | — |
| Changes from baseline praxis at one year and at two years | Baseline (at inclusion), one year and two years | Production of symbolic gesture, imitation utilization gesture, non sense gesture imitation |
| Changes from baseline depressive symptoms measured by the Montgomery and Asberg Depression Rating Scale at one year and at two years | Baseline (at inclusion), one year and two years | — |
| Changes from baseline language measured by the test de denomination orale d'images (DO-80) at one year and at two years | Baseline (at inclusion), one year and two years | — |
Countries
France
Outcome results
None listed