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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02185222
Other study ID # SERC12-TC / D-COG
Secondary ID 2013-005110-36
Status Completed
Phase Phase 3
First received
Last updated
Start date October 23, 2014
Est. completion date October 10, 2018

Study information

Verified date November 2020
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date October 10, 2018
Est. primary completion date October 10, 2018
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Cholecalciferol 100 000 UI
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
Placebo
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years

Locations

Country Name City State
France 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 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 CHRU TOURS - Hôpital Bretonneau Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Evolution of anaemia evaluated by red blood cells count Baseline (pre-inclusion), one year and two years
Secondary Evolution of plasma calcium and albumin concentration Baseline (pre-inclusion), 45 days, one year and two years
Secondary Evolution of urinary calcium and creatinine concentration 45 days, one year and two years
Secondary All adverse events Up to two years
Secondary Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance Baseline (pre-inclusion), one year and two years
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48) Baseline at inclusion
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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