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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02185222
Recruitment Status : Unknown
Verified June 2017 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : July 9, 2014
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

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.

Condition or disease Intervention/treatment Phase
Memory Disorders Age-Related Cognitive Decline Drug: Cholecalciferol 100 000 UI Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
Study Start Date : July 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Vitamin D

Arm Intervention/treatment
Experimental: Cholecalciferol 100 000 UI (Unité Internationale)
Oral solution in single-dose : 100 000 UI per month
Drug: Cholecalciferol 100 000 UI
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
Other Name: Uvedose

Placebo Comparator: Placebo
Oral solution in single-dose per month
Drug: Placebo
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02185222


Contacts
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Contact: Fanny HENNEKINNE, PH 0033247473713 fanny.hennekinne@univ-tours.fr

Locations
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France
Chu Angers Recruiting
Angers, France, 49933
Contact: Cédric ANNWEILER, PH       CeAnnweiler@chu-angers.fr   
Principal Investigator: Cédric ANNWEILER, PH         
CH BLOIS Recruiting
Blois, France
Contact: Patrick FRIOCOURT, PH       pfriocourt@ch-blois.fr   
Principal Investigator: Patrick FRIOCOURT, PH         
CHU BREST - Hôpital de la Cavale Blanche Not yet recruiting
Brest, France, 29200
Contact: Armelle GENTRIC, PU-PH       armelle.gentric@chu-brest.fr   
Principal Investigator: Armelle GENTRIC, PU-PH         
CHI ELBEUF Louviers Val-de-Reuil Recruiting
Elbeuf, France
Contact: Thibault SIMON, PH       thibault.simon@chi-elbeuf-louviers.fr   
Principal Investigator: Thibault SIMON, PH         
CHU NANTES - Hôpital Bellier Recruiting
Nantes, France, 44093
Contact: Sophie PICHIERRI, PH       sophie.pichierri@chu-nantes.fr   
Principal Investigator: Sophie PICHIERRI, PH         
CHU NANTES - Hôpital Laënnec Recruiting
Nantes, France, 44093
Contact: Claire BOUTOLEAU-BRETONNIERE       claire.boutoleaubretonniere@chu-nantes.fr   
Principal Investigator: Claire BOUTOLEAU-BRETONNIERE, PH         
Chr Orleans Recruiting
Orléans, France, 45067
Contact: Jean-Bernard GAUVAIN, PH       jean-bernard.gauvain@chr-orleans.fr   
Principal Investigator: Jean-Bernard GAUVAIN, PH         
CHU POITIERS - Hôpital de la Milétrie Recruiting
Poitiers, France, 86021
Contact: Marc PACCALIN, PU-PH       m.paccalin@chu-poitiers.fr   
Principal Investigator: Marc PACCALIN, PU-PH         
CHU RENNES - Hôpital Hôtel Dieu Recruiting
Rennes, France, 35064
Contact: Aline CORVOL, PH       aline.corvol@chu-rennes.fr   
Principal Investigator: Aline CORVOL, PH         
CHU ROUEN - Hôpital Charles Nicolle Recruiting
Rouen, France, 76031
Contact: Caroline LEVASSEUR, PH       caroline.levasseur@chu-rouen.fr   
Principal Investigator: Caroline LEVASSEUR, PH         
CHRU TOURS - Hôpital Bretonneau Not yet recruiting
Tours, France, 37044
Contact: Fanny HENNEKINNE, PH       fanny.hennekinne@univ-tours.fr   
Principal Investigator: Fanny HENNEKINNE, PH         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Fanny HENNEKINE, PH CHRU TOURS - Hôpital Bretonneau
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02185222    
Other Study ID Numbers: SERC12-TC / D-COG
2013-005110-36 ( EudraCT Number )
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Keywords provided by University Hospital, Tours:
Vitamin D
Cholecalciferol
25-hydroxyvitamin D
Memory complaint
Subjective memory complaint
Mild cognitive impairment
Preventive therapy
Cognitive disorders
Additional relevant MeSH terms:
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Memory Disorders
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Cholecalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents