Memory DisordersPhase 3D-COGNCT02185222
Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
A Phase 3 study testing Cholecalciferol 100 000 UI in people with Memory Disorders and Age-Related Cognitive Decline, run by University Hospital, Tours at 11 sites in France.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Memory Disorders, Age-Related Cognitive Decline
- What is being tested?
- Cholecalciferol 100 000 UI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 11 sitesFrance
- Study dates
- 23 Oct 2014to 10 Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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),
Show all 21Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Chu Angers
Angers, 49933
CH BLOIS
Blois
CHU BREST - Hôpital de la Cavale Blanche
Brest, 29200
CHI ELBEUF Louviers Val-de-Reuil
Elbeuf
CHU NANTES - Hôpital Bellier
Nantes, 44093
CHU NANTES - Hôpital Laënnec
Nantes, 44093
Chr Orleans
Orléans, 45067
CHU POITIERS - Hôpital de la Milétrie
Poitiers, 86021
CHU RENNES - Hôpital Hôtel Dieu
Rennes, 35064
CHU ROUEN - Hôpital Charles Nicolle
Rouen, 76031
CHRU TOURS - Hôpital Bretonneau
Tours, 37044
About this study
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.
- Conditions
- Memory Disorders, Age-Related Cognitive Decline
- Being tested
- Cholecalciferol 100 000 UI, Placebo
- Keywords
- Vitamin D, Cholecalciferol, 25-hydroxyvitamin D, Memory complaint, Subjective memory complaint, Mild cognitive impairment, Preventive therapy, Cognitive disorders
- Medical subject headings
- Memory Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol 100 000 UIDrug
Also called Uvedose
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
PlaceboDrug
Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol 100 000 UI (Unité Internationale) | Experimental | Oral solution in single-dose : 100 000 UI per month Receives: Drug: Cholecalciferol 100 000 UI |
| Placebo | Placebo comparator | Oral solution in single-dose per month Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at inclusion), one year and two years
Secondary outcomes (19)
Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years
Measured: Baseline (inclusion), one year and two years
Evolution of anaemia evaluated by red blood cells count
Measured: Baseline (pre-inclusion), one year and two years
Evolution of plasma calcium and albumin concentration
Measured: Baseline (pre-inclusion), 45 days, one year and two years
Evolution of urinary calcium and creatinine concentration
Measured: 45 days, one year and two years
All adverse events
Measured: Up to two years
Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance
Measured: Baseline (pre-inclusion), one year and two years
Changes from baseline global efficiency measured by the Mini Mental State Examination at one year and at two years
Measured: Baseline (at inclusion), one year and two years
Changes from baseline global efficiency measured by the Montreal Cognitive Assessment at one year and at two years
Measured: Baseline (at inclusion), one year and two years
Changes from baseline instrumental activity of daily living measured by 8 items at one year and at two years
Measured: Baseline (at inclusion), one year and two years
Changes from baseline language measured by the "test de denomination orale d'images" (DO-80) at one year and at two years
Measured: Baseline (at inclusion), one year and two years
Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48)
Measured: Baseline at inclusion
Changes from baseline executive functions measured by the stroop test at one year and at two years
Measured: Baseline (at inclusion), one year and two years
Changes from baseline executive functions measured by the verbal fluency at one year and at two years
Measured: Baseline (at inclusion), one year and two years
Changes from baseline executive functions measured by the Trail Making Test part B at one year and at two years
Measured: Baseline (at inclusion), one year and two years
Changes from baseline attention and speed processing measured by the Trail Making Test part A at one year and at two years
Measured: Baseline (at inclusion), one year and two years
Changes from baseline attention and speed processing measured by the Digit symbol test at one year and at two years
Measured: Baseline (at inclusion), one year and two years
Changes from baseline visuospatial study measured by the Rey figure (copy) at one year and at two years
Measured: Baseline (at inclusion), one year and two years
Changes from baseline praxis at one year and at two years
Production of symbolic gesture, imitation utilization gesture, non sense gesture imitation
Measured: Baseline (at inclusion), one year and two years
Changes from baseline depressive symptoms measured by the Montgomery and Asberg Depression Rating Scale at one year and at two years
Measured: Baseline (at inclusion), one year and two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study start23 Oct 2014
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny HENNEKINE, PH, Principal investigator, CHRU TOURS - Hôpital Bretonneau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185222
- Sponsor's protocol ID
- SERC12-TC / D-COG
- Other IDs
- 2013-005110-36
- Acronym
- D-COG
- Status last verified
- Nov 2020
- First submitted
- 30 Jun 2014
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
- ClinicalTrials.gov ID
- NCT02185222
- Acronym / sponsor ID
- D-COG / SERC12-TC / D-COG
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol 100 000 UI (Unité Internationale) | Experimental | Drug: Cholecalciferol 100 000 UIOral solution in single-dose : 100 000 UI per month |
| Placebo | Placebo comparator | Drug: PlaceboOral solution in single-dose per month |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (21 listed)
- Alzheimer's disease or other dementia,
- Parkinson's disease treated,
- Epilepsy treated,
- Huntington's disease,
- Brain tumor,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecalciferol 100 000 UIAlso: UvedoseStudy of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years | Drug | Cholecalciferol 100 000 UI (Unité Internationale) |
| PlaceboStudy of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years | Drug | Placebo |
Primary outcome
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.
19 secondary outcomes
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
Evolution of anaemia evaluated by red blood cells count
Time frame: Baseline (pre-inclusion), one year and two years
Evolution of plasma calcium and albumin concentration
Time frame: Baseline (pre-inclusion), 45 days, one year and two years
Evolution of urinary calcium and creatinine concentration
Time frame: 45 days, one year and two years
All adverse events
Time frame: Up to two years
Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance
Time frame: Baseline (pre-inclusion), one year and two years
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
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
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
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
Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48)
Time frame: Baseline at inclusion
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
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
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
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
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
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
Changes from baseline praxis at one year and at two years
Time frame: Baseline (at inclusion), one year and two years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny HENNEKINE, PH principal investigator
CHRU TOURS - Hôpital Bretonneau
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cholecalciferol 100 000 UI in people with Memory Disorders and Age-Related Cognitive Decline, run by University Hospital, Tours at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.