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

• ClinicalTrials.gov Identifier: NCT02185222
• Recruitment Status: Completed
• First Posted: July 9, 2014
• Last Update Posted: November 4, 2020
• Sponsor: University Hospital, Tours
• Information provided by (Responsible Party): University Hospital, Tours

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Study Start Date: October 23, 2014
• Actual Primary Completion Date: October 10, 2018
• Actual Study Completion Date: October 10, 2018

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

France

Chu Angers

Angers, France, 49933

CH BLOIS

Blois, France

CHU BREST - Hôpital de la Cavale Blanche

Brest, France, 29200

CHI ELBEUF Louviers Val-de-Reuil

Elbeuf, France

CHU NANTES - Hôpital Bellier

Nantes, France, 44093

CHU NANTES - Hôpital Laënnec

Nantes, France, 44093

Chr Orleans

Orléans, France, 45067

CHU POITIERS - Hôpital de la Milétrie

Poitiers, France, 86021

CHU RENNES - Hôpital Hôtel Dieu

Rennes, France, 35064

CHU ROUEN - Hôpital Charles Nicolle

Rouen, France, 76031

CHRU TOURS - Hôpital Bretonneau

Tours, France, 37044

Sponsors and Collaborators

University Hospital, Tours

Investigators

• Principal Investigator: Fanny HENNEKINE, PH; CHRU TOURS - Hôpital Bretonneau

More Information

• 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
• Last Update Posted: November 4, 2020
• Last Verified: November 2020

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:

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