Clinical trial NCT02185222: Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
Official title: Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Memory Disorders
Age-Related Cognitive Decline
Keywords: Vitamin D
Cholecalciferol
25-hydroxyvitamin D
Memory complaint
Subjective memory complaint
Mild cognitive impairment
Preventive therapy
Cognitive disorders
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 68
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Baseline (at inclusion), one year and two years
Secondary outcomes:
measure: Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years
timeFrame: Baseline (inclusion), one year and two years
measure: Evolution of anaemia evaluated by red blood cells count
timeFrame: Baseline (pre-inclusion), one year and two years
measure: Evolution of plasma calcium and albumin concentration
timeFrame: Baseline (pre-inclusion), 45 days, one year and two years
measure: Evolution of urinary calcium and creatinine concentration
timeFrame: 45 days, one year and two years
measure: All adverse events
timeFrame: Up to two years
measure: Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance
timeFrame: Baseline (pre-inclusion), one year and two years
measure: Changes from baseline global efficiency measured by the Mini Mental State Examination at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
measure: Changes from baseline global efficiency measured by the Montreal Cognitive Assessment at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
measure: Changes from baseline instrumental activity of daily living measured by 8 items at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
measure: Changes from baseline language measured by the "test de denomination orale d'images" (DO-80) at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
measure: Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48)
timeFrame: Baseline at inclusion
measure: Changes from baseline executive functions measured by the stroop test at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
measure: Changes from baseline executive functions measured by the verbal fluency at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
measure: Changes from baseline executive functions measured by the Trail Making Test part B at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
measure: Changes from baseline attention and speed processing measured by the Trail Making Test part A at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
measure: Changes from baseline attention and speed processing measured by the Digit symbol test at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
measure: Changes from baseline visuospatial study measured by the Rey figure (copy) at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
measure: Changes from baseline praxis at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
measure: Changes from baseline depressive symptoms measured by the Montgomery and Asberg Depression Rating Scale at one year and at two years
timeFrame: Baseline (at inclusion), one year and two years
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: Blois
country: France
facility: CH BLOIS
city: Brest
country: France
facility: CHU BREST - Hôpital de la Cavale Blanche
city: Elbeuf
country: France
facility: CHI ELBEUF Louviers Val-de-Reuil
city: Nantes
country: France
facility: CHU NANTES - Hôpital Bellier
city: Nantes
country: France
facility: CHU NANTES - Hôpital Laënnec
city: Orléans
country: France
facility: Chr Orleans
city: Poitiers
country: France
facility: CHU POITIERS - Hôpital de la Milétrie
city: Rennes
country: France
facility: CHU RENNES - Hôpital Hôtel Dieu
city: Rouen
country: France
facility: CHU ROUEN - Hôpital Charles Nicolle
city: Tours
country: France
facility: CHRU TOURS - Hôpital Bretonneau
Study officials:
affiliation: CHRU TOURS - Hôpital Bretonneau
name: Fanny HENNEKINE, PH
role: PRINCIPAL_INVESTIGATOR
References: