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Completed

NCT Number: NCT02185222

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

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.

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Key information

Conditions

Memory Disorders Age-related Cognitive Decline Cognition Disorders Cognitive Dysfunction Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chu Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cholecalciferol 100 000 UI

Drug

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

Other names: Uvedose

Placebo

Drug

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

Primary outcomes

  1. 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

    Time frame: Baseline (at inclusion), one year and 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.

Secondary outcomes

  1. Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years

    Time frame: Baseline (inclusion), one year and two years

  2. Evolution of anaemia evaluated by red blood cells count

    Time frame: Baseline (pre-inclusion), one year and two years

  3. Evolution of plasma calcium and albumin concentration

    Time frame: Baseline (pre-inclusion), 45 days, one year and two years

  4. Evolution of urinary calcium and creatinine concentration

    Time frame: 45 days, one year and two years

  5. All adverse events

    Time frame: Up to two years

  6. Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance

    Time frame: Baseline (pre-inclusion), one year and two years

  7. Changes from baseline global efficiency measured by the Mini Mental State Examination at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

  8. Changes from baseline global efficiency measured by the Montreal Cognitive Assessment at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

  9. Changes from baseline instrumental activity of daily living measured by 8 items at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

  10. Changes from baseline language measured by the "test de denomination orale d'images" (DO-80) at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

  11. Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48)

    Time frame: Baseline at inclusion

  12. Changes from baseline executive functions measured by the stroop test at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

  13. Changes from baseline executive functions measured by the verbal fluency at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

  14. Changes from baseline executive functions measured by the Trail Making Test part B at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

  15. Changes from baseline attention and speed processing measured by the Trail Making Test part A at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

  16. Changes from baseline attention and speed processing measured by the Digit symbol test at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

  17. Changes from baseline visuospatial study measured by the Rey figure (copy) at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

  18. Changes from baseline praxis at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

    Production of symbolic gesture, imitation utilization gesture, non sense gesture imitation

  19. Changes from baseline depressive symptoms measured by the Montgomery and Asberg Depression Rating Scale at one year and at two years

    Time frame: Baseline (at inclusion), one year and two years

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: D-COG

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 9, 2014
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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