Memory Complaint Without Cognitive DeclinePhase 2/3GAME-D2NCT02086409
GAit, MEmory, Dietary and Vitamin D
A Phase 2/3 study testing Yogurt supplemented with vitamin D and calcium and Yogurt not supplemented with vitamin D and calcium in people with Memory Complaint Without Cognitive Decline, run by University Hospital, Angers at 1 site in France.
Trial summary
Gait and posture disorders are very common in subjects aged 65 and over, and result mainly from neuromuscular and cognitive disorders. Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive performances… Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Memory Complaint Without Cognitive Decline
- What is being tested?
- Yogurt supplemented with vitamin D and calcium and Yogurt not supplemented with vitamin D and calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Apr 2015
- 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Woman aged 65 and over
- 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)
- Ability to walk a distance of 15 meters unaided
- Ability to eat 2 yogurts per day
- Memory complaint without cognitive decline
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- To have given and signed an informed consent to participate in the trial
- To be affiliated to French Social Security
- To have no vitamin D supplementation during inclusion
Who cannot join
- Existence of dementia according to DSM-IV and NINCDS-ADRDA criteria and others cognitive disorders: untreated thyroid dysfunction, chronic ongoing ethylism, history of syphilis, stroke with sequelae, depressive symptomatology (Geriatric Depression Scale > 5/15)
- Osteoarticular diseases of the lower members and / or spine altering the biomechanical characteristics of the body.
- Vitamin D supplementation during inclusion
- Contraindications to vitamin D
- Unstable medical condition
- Dairy allergy
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- Taste of dairy products not supported
- Enrolment in another simultaneous clinical trial
- Civil defense measures underway
- Refusal to participate of the subject
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire d'Angers
Angers, Maine et Loire, 49933
About this study
Official title: Dairy Product, Calcium & Vitamin D Supplementation and Cognitive-motor Function
Gait and posture disorders are very common in subjects aged 65 and over, and result mainly from neuromuscular and cognitive disorders.
Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive performances and are more prone to fail than individuals with no hypovitaminosis D, 3) the intake of vitamin D combined or not with calcium may improve muscle strength and cognitive performance.
The investigators hypothesized that the daily intake of 2 yogurts containing 200 IU of vitamin D and 400 mg of calcium 1) can improve spatiotemporal gait parameters, posture and executive performance, 2) and that this improvement depends of the initial level of vitamin D deficiency.
- Being tested
- Yogurt supplemented with vitamin D and calcium, Yogurt not supplemented with vitamin D and calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt supplemented with vitamin D and calciumDietary supplement
The product is a yogurt containing 200 IU of vitamin D and 400 mg of calcium. Participants take 2 yogurts per day.
Yogurt not supplemented with vitamin D and calciumDietary supplement
The comparator is represented by a yogurt not supplemented with vitamin D and calcium.Participants take 2 yogurts per day.
| Study group | Role | What they receive |
|---|---|---|
| Yogurt supplemented with vitamin D and calcium | Experimental | 20 participants take yogurt supplemented with vitamin D and calcium during 12 weeks Receives: Dietary Supplement: Yogurt supplemented with vitamin D and calcium |
| Yogurt not supplemented with vitamin D and calcium | Active comparator | 20 participants take yogurt not supplemented with vitamin D and calcium during 12 weeks Receives: Dietary Supplement: Yogurt not supplemented with vitamin D and calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spatiotemporal gait, and in particular in the variability of stride time
Stride time variability is measured with spatiotemporal analysis of walking
Measured: This outcome is assessed at baseline and 12 weeks after oral intake.
Secondary outcomes (6)
Change in posture
Posture is evaluated with Time Up \& Go, Five Time Sit-to-Stand and posture analysis with a platform.
Measured: This outcome is assessed at baseline and 12 weeks after oral intake.
Change in grip strength
Grip strength is measured with a dynamometer.
Measured: This outcome is assessed at baseline and 12 weeks after oral intake.
Change in executive performance
Executive performance is measured with Trial Making Test part B (TMT B)
Measured: This outcome is assessed at baseline and 12 weeks after oral intake.
Change in other cognitive scores
Executive scores are assessed with digit span test (forward and backward), Trial Making Test part A (TMT A), Stoop test and Processing Speed Index
Measured: These outcomes are assessed at baseline and 12 weeks after oral intake.
Change in the serum concentration of 25 OHD
This outcome is assessed with the serum concentrations of 25OHD
Measured: This outcome is assessed at baseline and 12 weeks after oral intake.
Compliance to intervention
Compliance is measured by the number of yogurt capsules returned
Measured: This outcome is assessed 12 weeks after oral intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory Complaint Without Cognitive DeclineStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086409
- Sponsor's protocol ID
- 2013-A01499-36
- Acronym
- GAME-D2
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2014
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dairy Product, Calcium & Vitamin D Supplementation and Cognitive-motor Function
- ClinicalTrials.gov ID
- NCT02086409
- Acronym / sponsor ID
- GAME-D2 / 2013-A01499-36
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Mar 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.
Gait and posture disorders are very common in subjects aged 65 and over, and result mainly from neuromuscular and cognitive disorders.
Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive performances and are more prone to fail than individuals with no hypovitaminosis D, 3) the intake of vitamin D combined or not with calcium may improve muscle strength and cognitive performance.
The investigators hypothesized that the daily intake of 2 yogurts containing 200 IU of vitamin D and 400 mg of calcium 1) can improve spatiotemporal gait parameters, posture and executive performance, 2) and that this improvement depends of the initial level of vitamin D deficiency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yogurt supplemented with vitamin D and calcium | Experimental | Dietary Supplement: Yogurt supplemented with vitamin D and calcium20 participants take yogurt supplemented with vitamin D and calcium during 12 weeks |
| Yogurt not supplemented with vitamin D and calcium | Active comparator | Dietary Supplement: Yogurt not supplemented with vitamin D and calcium20 participants take yogurt not supplemented with vitamin D and calcium during 12 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Woman aged 65 and over
- 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)
- Ability to walk a distance of 15 meters unaided
- Ability to eat 2 yogurts per day
Key exclusion criteria (10 listed)
- Existence of dementia according to DSM-IV and NINCDS-ADRDA criteria and others cognitive disorders: untreated thyroid dysfunction, chronic ongoing ethylism, history of syphilis, stroke with sequelae, depressive symptomatology (Geriatric Depression Scale > 5/15)
- Osteoarticular diseases of the lower members and / or spine altering the biomechanical characteristics of the body.
- Vitamin D supplementation during inclusion
- Contraindications to vitamin D
- Unstable medical condition
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 |
|---|---|---|
| Yogurt supplemented with vitamin D and calciumThe product is a yogurt containing 200 IU of vitamin D and 400 mg of calcium. Participants take 2 yogurts per day. | Dietary supplement | Yogurt supplemented with vitamin D and calcium |
| Yogurt not supplemented with vitamin D and calciumThe comparator is represented by a yogurt not supplemented with vitamin D and calcium.Participants take 2 yogurts per day. | Dietary supplement | Yogurt not supplemented with vitamin D and calcium |
Primary outcome
Change in spatiotemporal gait, and in particular in the variability of stride time
Time frame: This outcome is assessed at baseline and 12 weeks after oral intake.
Stride time variability is measured with spatiotemporal analysis of walking
6 secondary outcomes
Change in posture
Time frame: This outcome is assessed at baseline and 12 weeks after oral intake.
Change in grip strength
Time frame: This outcome is assessed at baseline and 12 weeks after oral intake.
Change in executive performance
Time frame: This outcome is assessed at baseline and 12 weeks after oral intake.
Change in other cognitive scores
Time frame: These outcomes are assessed at baseline and 12 weeks after oral intake.
Change in the serum concentration of 25 OHD
Time frame: This outcome is assessed at baseline and 12 weeks after oral intake.
Compliance to intervention
Time frame: This outcome is assessed 12 weeks after oral intake.
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 22 Sep 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Yogurt supplemented with vitamin D and calcium and Yogurt not supplemented with vitamin D and calcium in people with Memory Complaint Without Cognitive Decline, 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 9 inclusion and 10 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 22 Sep 2016. 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. 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?
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?
Change in spatiotemporal gait, and in particular in the variability of stride time (time frame: This outcome is assessed at baseline and 12 weeks after oral intake.). 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 22 Sep 2016.