Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
Phase 3
Completed
- Conditions
- Memory DisordersAge-Related Cognitive Decline
- Interventions
- Drug: Placebo
- Registration Number
- NCT02185222
- Lead Sponsor
- University Hospital, Tours
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral solution in single-dose per month Cholecalciferol 100 000 UI (Unité Internationale) Cholecalciferol 100 000 UI Oral solution in single-dose : 100 000 UI per month
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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
Trial Locations
- Locations (11)
CH BLOIS
🇫🇷Blois, France
CHU RENNES - Hôpital Hôtel Dieu
🇫🇷Rennes, France
Chu Angers
🇫🇷Angers, France
CHU BREST - Hôpital de la Cavale Blanche
🇫🇷Brest, France
CHU NANTES - Hôpital Laënnec
🇫🇷Nantes, France
CHI ELBEUF Louviers Val-de-Reuil
🇫🇷Elbeuf, France
Chr Orleans
🇫🇷Orléans, France
CHU NANTES - Hôpital Bellier
🇫🇷Nantes, France
CHU ROUEN - Hôpital Charles Nicolle
🇫🇷Rouen, France
CHRU TOURS - Hôpital Bretonneau
🇫🇷Tours, France
CHU POITIERS - Hôpital de la Milétrie
🇫🇷Poitiers, France