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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005110-36 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol 100 000 UI (Unité Internationale) | Experimental | Oral solution in single-dose : 100 000 UI per month |
|
| Placebo | Placebo Comparator | Oral solution in single-dose per month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol 100 000 UI | Drug | Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Baseline (at inclusion), one year and two years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Pre-Inclusion Criteria :
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fanny HENNEKINE, PH | CHRU TOURS - Hôpital Bretonneau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Angers | Angers | 49933 | France | |||
| CH BLOIS |
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| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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|
| Placebo | Drug | Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during 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 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 |
| 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 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 |
| 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 | Production of symbolic gesture, imitation utilization gesture, non sense gesture imitation | Baseline (at inclusion), one year and two years |
| 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 |
| Blois |
| France |
| CHU BREST - Hôpital de la Cavale Blanche | Brest | 29200 | France |
| CHI ELBEUF Louviers Val-de-Reuil | Elbeuf | France |
| CHU NANTES - Hôpital Bellier | Nantes | 44093 | France |
| CHU NANTES - Hôpital Laënnec | Nantes | 44093 | France |
| Chr Orleans | Orléans | 45067 | France |
| CHU POITIERS - Hôpital de la Milétrie | Poitiers | 86021 | France |
| CHU RENNES - Hôpital Hôtel Dieu | Rennes | 35064 | France |
| CHU ROUEN - Hôpital Charles Nicolle | Rouen | 76031 | France |
| CHRU TOURS - Hôpital Bretonneau | Tours | 37044 | France |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |