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

Last updated: November 3, 2020
Sponsor: University Hospital, Tours
Overall Status: Completed

Phase

3

Condition

Memory Loss

Aging

Mental Disability

Treatment

N/A

Clinical Study ID

NCT02185222
SERC12-TC / D-COG
2013-005110-36
  • Ages > 60
  • All Genders

Study 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

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 forsociocultural level of the patient (GRECO standards for elderly patients),
  • Having visual, hearing abilities (authorized equipment) and an oral or writtenexpression 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

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 nervoussystem (blood pressure, higher or equal to 180/100 mmHg, chronic pulmonary diseasewith hypoxia; cerebrovascular accident of less than 3 months, cranial traumatism withpersistent neurologic deficit, subdural hematoma, brain surgery),
  • Antecedent of alcoholism or chronic drug-addiction with an obvious or documentedconsequence 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 CognitiveImpairment) of less than 6 months is not a criterion of non-inclusion.

Study Design

Total Participants: 68
Study Start date:
October 23, 2014
Estimated Completion Date:
October 10, 2018

Connect with a study center

  • Chu Angers

    Angers, 49933
    France

    Site Not Available

  • CH BLOIS

    Blois,
    France

    Site Not Available

  • CHU BREST - Hôpital de la Cavale Blanche

    Brest, 29200
    France

    Site Not Available

  • CHI ELBEUF Louviers Val-de-Reuil

    Elbeuf,
    France

    Site Not Available

  • CHU NANTES - Hôpital Bellier

    Nantes, 44093
    France

    Site Not Available

  • CHU NANTES - Hôpital Laënnec

    Nantes, 44093
    France

    Site Not Available

  • Chr Orleans

    Orléans, 45067
    France

    Site Not Available

  • CHU POITIERS - Hôpital de la Milétrie

    Poitiers, 86021
    France

    Site Not Available

  • CHU RENNES - Hôpital Hôtel Dieu

    Rennes, 35064
    France

    Site Not Available

  • CHU ROUEN - Hôpital Charles Nicolle

    Rouen, 76031
    France

    Site Not Available

  • CHRU TOURS - Hôpital Bretonneau

    Tours, 37044
    France

    Site Not Available

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