Mild Cognitive ImpairmentPhase 2/3DIET-DNCT01708005
DIetary Supplements, Executive funcTions and Vitamin D (DIET-D)
A Phase 2/3 study testing Lecitone®Se-Vitamin D3 in people with Mild Cognitive Impairment, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to compare the effect after 12 weeks of the oral intake of Lecitone®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive performance in Trial Making Test score part B (this test evaluate executive functions of mental flexibility) in older adults with Mild… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Lecitone®Se-Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Nov 2014
- Phase
- Phase 2/3
- 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
- Age ≥ 60 years
- Memory complaints
- No dementia (DSM-IV, NINCDS-ADRDA negative)
- No depression (Geriatric Depression score ≤ 5/15)
- Ability to walk a distance of 15 meters unaided
- Diagnosis of MCI
Show all 10Show fewer
- To have hypovitaminosis D (i.e. serum 25-hydroxyvitamin D [25OHD]concentration ≤ 30ng/mL)
- To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65mmol/L)
- To have given and signed an informed consent to participate in the trial
- To be affiliated to French Social Security
Who cannot join
- Others cognitive disorders (untreated thyroid dysfunction, chronic ongoing ethylism, history of syphilis, stroke, severe depressive symptomatology (Geriatric Depression score > 5/15), existence of dementia according to DSM-IV and NINCDS-ADRDA criteria at the time of inclusion)
- Vitamin D supplementation during inclusion
- Contraindications to vitamin D
- Unstable medical condition
- Enrollment in another simultaneous clinical trial
- Civil defense measures underway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial
The purpose of this study is to compare the effect after 12 weeks of the oral intake of Lecitone®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive performance in Trial Making Test score part B (this test evaluate executive functions of mental flexibility) in older adults with Mild Cognitive Impairment (MCI).
Read the detailed description
Current treatments for Alzheimer's disease (AD) are symptomatic and can only temporarily slow down AD without altering its natural evolution. The development of new therapies has primarily focused on preventing the progression of AD. This therapeutic strategy involves being interested in patients with an early stage of AD such as a mild cognitive impairment (MCI). We hypothesized that the combination of Lecitone®Se with 200 IU/day of vitamin D can slow or even improve cognitive decline, particularly executive functions.
The primary objective of this trial is to compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in performance obtained in the TMT B in the older adults with a MCI.
The secondary objectives of the study are as follows:
- To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in executive performance in patients with a MCI.
- To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in variability of stride time in patients with a MCI.
- To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo and a delay phase of supplementation on changes in executive performance in patients with a MCI.
- To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo and a delay phase of supplementation on changes in variability of stride time in patients with a MCI.
- To determine the compliance and tolerance of the oral intake of Lecitone®Se-Vitamin D3 in patients with a MCI.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Lecitone®Se-Vitamin D3, Placebo
- Keywords
- Mild Cognitive Impairment, Vitamin D, Cholecalciferol, Lecitone®Se-Vitamin D3
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lecitone®Se-Vitamin D3Drug
Lecitone®Se-Vitamin D3 is a dietary supplement combining the active ingredients in Lecitone®Se and 100 IU of vitamin D3. This dietary supplement comes in capsule form.
Participants take 2 capsules of Lecitone®Se -Vitamin D3 per day. The dose of vitamin D supplementation will not be adjusted except in case of an adverse event such as hypercalcemia. In this case, vitamin D supplementation is stopped and the participant is released prematurely from the study.
PlaceboDrug
The comparator is represented by placebo capsules of identical appearance (same size, same color and same smell) that Lecitone®Se-Vitamin D3 capsules.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 80 participants start the oral intake of Lecitone®Se-Vitamin D3 the day after inclusion and during 24 weeks Receives: Drug: Lecitone®Se-Vitamin D3 |
| Placebo | Placebo comparator | 80 participants in this arm start the oral intake of placebo the day after inclusion and during 12 weeks.
Then, they start the oral intake of Lecitone®Se-Vitamin D3 12 weeks after inclusion until the 24th week. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in executive performance
Executive performance is measured with Trial Making Test part B (TMT B)
Measured: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
Secondary outcomes (5)
Change in other executive scores
Test parts A and B, Stoop test, Processing Speed Index
Measured: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
Change in posture
Time Up \& Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
Measured: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
Between-group comparison of compliance to treatment
This outcome is assessed together with the serum concentrations of 25OHD and calcium
Measured: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
Change in gait
Time Up \& Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
Measured: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Between-group comparison of tolerance
This outcome is assessed with the serum concentrations of 25OHD and calcium
Measured: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Nantes University Hospital, NUTRISANTE
- Responsible party
- Sponsor
- Investigators
- Olivier Beauchet, MD,PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708005
- Sponsor's protocol ID
- 2012-A00453-40
- Acronym
- DIET-D
- Status last verified
- Oct 2012
- First submitted
- 9 Oct 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01708005
- Acronym / sponsor ID
- DIET-D / 2012-A00453-40
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Vitamin D, Cholecalciferol, Lecitone®Se-Vitamin D3
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Nantes University Hospital, NUTRISANTE
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 16 Oct 2012 (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.
The purpose of this study is to compare the effect after 12 weeks of the oral intake of Lecitone®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive performance in Trial Making Test score part B (this test evaluate executive functions of mental flexibility) in older adults with Mild Cognitive Impairment (MCI).
Detailed description
Current treatments for Alzheimer's disease (AD) are symptomatic and can only temporarily slow down AD without altering its natural evolution. The development of new therapies has primarily focused on preventing the progression of AD. This therapeutic strategy involves being interested in patients with an early stage of AD such as a mild cognitive impairment (MCI). We hypothesized that the combination of Lecitone®Se with 200 IU/day of vitamin D can slow or even improve cognitive decline, particularly executive functions.
The primary objective of this trial is to compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in performance obtained in the TMT B in the older adults with a MCI.
The secondary objectives of the study are as follows:
- To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in executive performance in patients with a MCI.
- To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in variability of stride time in patients with a MCI.
- To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo and a delay phase of supplementation on changes in executive performance in patients with a MCI.
- To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo and a delay phase of supplementation on changes in variability of stride time in patients with a MCI.
- To determine the compliance and tolerance of the oral intake of Lecitone®Se-Vitamin D3 in patients with a MCI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Lecitone®Se-Vitamin D380 participants start the oral intake of Lecitone®Se-Vitamin D3 the day after inclusion and during 24 weeks |
| Placebo | Placebo comparator | Drug: Placebo80 participants in this arm start the oral intake of placebo the day after inclusion and during 12 weeks. Then, they start the oral intake of Lecitone®Se-Vitamin D3 12 weeks after inclusion until the 24th week. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 60 years
- Memory complaints
- No dementia (DSM-IV, NINCDS-ADRDA negative)
- No depression (Geriatric Depression score ≤ 5/15)
- Ability to walk a distance of 15 meters unaided
Key exclusion criteria (6 listed)
- Others cognitive disorders (untreated thyroid dysfunction, chronic ongoing ethylism, history of syphilis, stroke, severe depressive symptomatology (Geriatric Depression score > 5/15), existence of dementia according to DSM-IV and NINCDS-ADRDA criteria at the time of inclusion)
- Vitamin D supplementation during inclusion
- Contraindications to vitamin D
- Unstable medical condition
- Enrollment in another simultaneous clinical trial
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 |
|---|---|---|
| Lecitone®Se-Vitamin D3Lecitone®Se-Vitamin D3 is a dietary supplement combining the active ingredients in Lecitone®Se and 100 IU of vitamin D3. This dietary supplement comes in capsule form. Participants take 2 capsules of Lecitone®Se -Vitamin D3 per day. The dose of vitamin D supplementation will not be adjusted except in case of an adverse event such as hypercalcemia. In this case, vitamin D supplementation is stopped and the participant is released prematurely from the study. | Drug | Intervention |
| PlaceboThe comparator is represented by placebo capsules of identical appearance (same size, same color and same smell) that Lecitone®Se-Vitamin D3 capsules. | Drug | Placebo |
Primary outcome
Change in executive performance
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
Executive performance is measured with Trial Making Test part B (TMT B)
5 secondary outcomes
Change in other executive scores
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
Change in posture
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
Between-group comparison of compliance to treatment
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
Change in gait
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Between-group comparison of tolerance
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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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.
Olivier Beauchet, MD,PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lecitone®Se-Vitamin D3 in people with Mild Cognitive Impairment, run by University Hospital, Angers at 1 site 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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
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?
Change in executive performance (time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.). 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 16 Oct 2012.