Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint

NCT ID: NCT02185222

Last Updated: 2020-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-23
• Study Completion Date: 2018-10-10

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.

Conditions

Memory Disorders; Age-Related Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cholecalciferol 100 000 UI (Unité Internationale)

Oral solution in single-dose : 100 000 UI per month

Group Type: EXPERIMENTAL

Cholecalciferol 100 000 UI

Intervention Type: DRUG

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

Placebo

Oral solution in single-dose per month

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Cholecalciferol 100 000 UI

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Uvedose

Eligibility Criteria

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 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fanny HENNEKINE, PH

Role: PRINCIPAL_INVESTIGATOR

CHRU TOURS - Hôpital Bretonneau

Locations

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, , France

Countries

France

Other Identifiers

2013-005110-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SERC12-TC / D-COG

Identifier Type: -

Identifier Source: org_study_id