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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
Chu Angers
Angers, France
CH BLOIS
Blois, France
CHU BREST - Hôpital de la Cavale Blanche
Brest, France
CHI ELBEUF Louviers Val-de-Reuil
Elbeuf, France
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.
Time frame: Baseline (at inclusion), one year and two years
Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years
Time frame: Baseline (inclusion), one year and two years
Evolution of anaemia evaluated by red blood cells count
Time frame: Baseline (pre-inclusion), one year and two years
Evolution of plasma calcium and albumin concentration
Time frame: Baseline (pre-inclusion), 45 days, one year and two years
Evolution of urinary calcium and creatinine concentration
Time frame: 45 days, one year and two years
All adverse events
Time frame: Up to two years
Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance
Time frame: 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
Time frame: 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
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CHU NANTES - Hôpital Bellier
Nantes, France
CHU NANTES - Hôpital Laënnec
Nantes, France
Chr Orleans
Orléans, France
CHU POITIERS - Hôpital de la Milétrie
Poitiers, France
CHU RENNES - Hôpital Hôtel Dieu
Rennes, France
CHU ROUEN - Hôpital Charles Nicolle
Rouen, France
...and 1 more locations
Time frame: 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
Time frame: 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
Time frame: Baseline (at inclusion), one year and two years
Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48)
Time frame: Baseline at inclusion
Changes from baseline executive functions measured by the stroop test at one year and at two years
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (at inclusion), one year and two years