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Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint (D-COG)

Primary Purpose

Memory Disorders, Age-Related Cognitive Decline

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Cholecalciferol 100 000 UI
Placebo
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Memory Disorders focused on measuring Vitamin D, Cholecalciferol, 25-hydroxyvitamin D, Memory complaint, Subjective memory complaint, Mild cognitive impairment, Preventive therapy, Cognitive disorders

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chu Angers
  • CH BLOIS
  • CHU BREST - Hôpital de la Cavale Blanche
  • CHI ELBEUF Louviers Val-de-Reuil
  • CHU NANTES - Hôpital Bellier
  • CHU NANTES - Hôpital Laënnec
  • Chr Orleans
  • CHU POITIERS - Hôpital de la Milétrie
  • CHU RENNES - Hôpital Hôtel Dieu
  • CHU ROUEN - Hôpital Charles Nicolle
  • CHRU TOURS - Hôpital Bretonneau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cholecalciferol 100 000 UI (Unité Internationale)

Placebo

Arm Description

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

Oral solution in single-dose per month

Outcomes

Primary Outcome Measures

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
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 Outcome Measures

Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years
Evolution of anaemia evaluated by red blood cells count
Evolution of plasma calcium and albumin concentration
Evolution of urinary calcium and creatinine concentration
All adverse events
Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance
Changes from baseline global efficiency measured by the Mini Mental State Examination at one year and at two years
Changes from baseline global efficiency measured by the Montreal Cognitive Assessment at one year and at two years
Changes from baseline instrumental activity of daily living measured by 8 items at one year and at two years
Changes from baseline language measured by the "test de denomination orale d'images" (DO-80) at one year and at two years
Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48)
Changes from baseline executive functions measured by the stroop test at one year and at two years
Changes from baseline executive functions measured by the verbal fluency at one year and at two years
Changes from baseline executive functions measured by the Trail Making Test part B at one year and at two years
Changes from baseline attention and speed processing measured by the Trail Making Test part A at one year and at two years
Changes from baseline attention and speed processing measured by the Digit symbol test at one year and at two years
Changes from baseline visuospatial study measured by the Rey figure (copy) at one year and at two years
Changes from baseline praxis at one year and at two years
Production of symbolic gesture, imitation utilization gesture, non sense gesture imitation
Changes from baseline depressive symptoms measured by the Montgomery and Asberg Depression Rating Scale at one year and at two years

Full Information

First Posted
June 30, 2014
Last Updated
November 3, 2020
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02185222
Brief Title
Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
Acronym
D-COG
Official Title
Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2014 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol 100 000 UI (Unité Internationale)
Arm Type
Experimental
Arm Description
Oral solution in single-dose : 100 000 UI per month
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral solution in single-dose per month
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol 100 000 UI
Other Intervention Name(s)
Uvedose
Intervention Description
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline (at inclusion), one year and two years
Secondary Outcome Measure Information:
Title
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
Title
Evolution of anaemia evaluated by red blood cells count
Time Frame
Baseline (pre-inclusion), one year and two years
Title
Evolution of plasma calcium and albumin concentration
Time Frame
Baseline (pre-inclusion), 45 days, one year and two years
Title
Evolution of urinary calcium and creatinine concentration
Time Frame
45 days, one year and two years
Title
All adverse events
Time Frame
Up to two years
Title
Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance
Time Frame
Baseline (pre-inclusion), one year and two years
Title
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
Title
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
Title
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
Title
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
Title
Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48)
Time Frame
Baseline at inclusion
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Changes from baseline praxis at one year and at two years
Description
Production of symbolic gesture, imitation utilization gesture, non sense gesture imitation
Time Frame
Baseline (at inclusion), one year and two years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanny HENNEKINE, PH
Organizational Affiliation
CHRU TOURS - Hôpital Bretonneau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CH BLOIS
City
Blois
Country
France
Facility Name
CHU BREST - Hôpital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHI ELBEUF Louviers Val-de-Reuil
City
Elbeuf
Country
France
Facility Name
CHU NANTES - Hôpital Bellier
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU NANTES - Hôpital Laënnec
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Chr Orleans
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
CHU POITIERS - Hôpital de la Milétrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU RENNES - Hôpital Hôtel Dieu
City
Rennes
ZIP/Postal Code
35064
Country
France
Facility Name
CHU ROUEN - Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHRU TOURS - Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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

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