Status:
COMPLETED
Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
Lead Sponsor:
University Hospital, Tours
Conditions:
Memory Disorders
Age-Related Cognitive Decline
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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 recom...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
October 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2018
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT02185222
Start Date
October 23 2014
End Date
October 10 2018
Last Update
November 4 2020
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu Angers
Angers, France, 49933
2
CH BLOIS
Blois, France
3
CHU BREST - Hôpital de la Cavale Blanche
Brest, France, 29200
4
CHI ELBEUF Louviers Val-de-Reuil
Elbeuf, France