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

Memory Disorders Clinical Trial

— D-COG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185222
• Other study ID #: SERC12-TC / D-COG
• Secondary ID: 2013-005110-36
• Status: Completed
• Phase: Phase 3
• Start date: October 23, 2014
• Est. completion date: October 10, 2018

Study information

• Verified date: November 2020
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Cognitive Decline
• Cognitive Dysfunction
• Memory Disorders

Intervention

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

Locations

Country	Name	City	State
France	Chu Angers	Angers
France	CH BLOIS	Blois
France	CHU BREST - Hôpital de la Cavale Blanche	Brest
France	CHI ELBEUF Louviers Val-de-Reuil	Elbeuf
France	CHU NANTES - Hôpital Bellier	Nantes
France	CHU NANTES - Hôpital Laënnec	Nantes
France	Chr Orleans	Orléans
France	CHU POITIERS - Hôpital de la Milétrie	Poitiers
France	CHU RENNES - Hôpital Hôtel Dieu	Rennes
France	CHU ROUEN - Hôpital Charles Nicolle	Rouen
France	CHRU TOURS - Hôpital Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (at inclusion), one year and two years
Secondary	Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years		Baseline (inclusion), one year and two years
Secondary	Evolution of anaemia evaluated by red blood cells count		Baseline (pre-inclusion), one year and two years
Secondary	Evolution of plasma calcium and albumin concentration		Baseline (pre-inclusion), 45 days, one year and two years
Secondary	Evolution of urinary calcium and creatinine concentration		45 days, one year and two years
Secondary	All adverse events		Up to two years
Secondary	Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance		Baseline (pre-inclusion), one year and two years
Secondary	Changes from baseline global efficiency measured by the Mini Mental State Examination at one year and at two years		Baseline (at inclusion), one year and two years
Secondary	Changes from baseline global efficiency measured by the Montreal Cognitive Assessment at one year and at two years		Baseline (at inclusion), one year and two years
Secondary	Changes from baseline instrumental activity of daily living measured by 8 items at one year and at two years		Baseline (at inclusion), one year and two years
Secondary	Changes from baseline language measured by the "test de denomination orale d'images" (DO-80) at one year and at two years		Baseline (at inclusion), one year and two years
Secondary	Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48)		Baseline at inclusion
Secondary	Changes from baseline executive functions measured by the stroop test at one year and at two years		Baseline (at inclusion), one year and two years
Secondary	Changes from baseline executive functions measured by the verbal fluency at one year and at two years		Baseline (at inclusion), one year and two years
Secondary	Changes from baseline executive functions measured by the Trail Making Test part B at one year and at two years		Baseline (at inclusion), one year and two years
Secondary	Changes from baseline attention and speed processing measured by the Trail Making Test part A at one year and at two years		Baseline (at inclusion), one year and two years
Secondary	Changes from baseline attention and speed processing measured by the Digit symbol test at one year and at two years		Baseline (at inclusion), one year and two years
Secondary	Changes from baseline visuospatial study measured by the Rey figure (copy) at one year and at two years		Baseline (at inclusion), one year and two years
Secondary	Changes from baseline praxis at one year and at two years	Production of symbolic gesture, imitation utilization gesture, non sense gesture imitation	Baseline (at inclusion), one year and two years
Secondary	Changes from baseline depressive symptoms measured by the Montgomery and Asberg Depression Rating Scale at one year and at two years		Baseline (at inclusion), one year and two years