Accidental FallsVITADCOGNCT02517164
Role of Vitamin D Levels (Serum 25-hydroxyvitamin D) and Cognitive Impairment in the Occurrence of Falls
An observational study of Accidental Falls, run by University Hospital, Caen at 1 site in France.
Trial summary
Every year, nearly 30% of people aged over 65 fall at least once and about 15% fall at least twice. These falls can have serious consequences that are a significant threat to the independence and well-being of older people. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Measurement of serum 25-hydroxyvitamin D and Analysis of global cognitive efficiency score assessed by the "Montreal Cognitive Assessment" (MoCA).
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Dec 2015
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fallers and person at risk of falls aged at least 50 years
Who may be able to join
- Male or female patient, aged at least 50 years;
- Patient able to walk only 15 m, possibly helped by wearing a cane;
- For those aged 50 and over and having fallen: the victim of a fall from a height of uncomplicated fracture in the last 12 months; the fall occurred while standing, or walking, or from the sitting position;
- For those aged 50 and over at risk of falling: woman aged 75 and over, or about having one or more predisposing factors for falls, such as trouble walking or balance (test score the "timed up and got" ≥ 14 sec, muscle weakness of the lower limbs (≤ 4/5), visual disturbance (scale "Monoyer"; corrected visual acuity <10/20 for the sum of the two eyes), impaired lower limb proprioception (position sense test toes), depression (justifying drug therapy), cognitive disorders (MMS ≤ 26), parkinsonism (known diagnosis and clinical examination), osteoarthritis disrupting travel (known diagnosis and clinical and radiographic examinations), subject taking more than 4 drugs per day, taking psychotropic drugs.
Who cannot join
- The subject is a person deprived of liberty or an adult placed under guardianship;
- The inclusion of the subject in another biomedical research protocol for this study (unless prior approval of the principal investigator);
- The subject can walk only with the help of a third person or with the help of two canes or a walker;
- The subject is suffering from severe or progressive neurological condition;
- The subject has severe cognitive impairment (MMS <20)
- The subject has significant visual disturbances (corrected visual acuity <6/20 for the sum of 2 eyes)
Show all 14Show fewer
- The subject received a "loading dose" of vitamin D in the last 6 months (≥ 100,000 IU);
- For subjects who dropped:
- The fall was caused by a third party (eg stampede);
- The subject has not dropped its height (eg fall from a ladder);
- At the time of the fall, the subject ran or rolled cycling;
- The fall is the result of an accident of the public highway;
- The fall was the cause of a fracture;
- The last drop was more than 12 months.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Caen, 14000
Christian Marcelli, MD, PhD, 0231063093
Christian Marcelli, Professor
About this study
Every year, nearly 30% of people aged over 65 fall at least once and about 15% fall at least twice. These falls can have serious consequences that are a significant threat to the independence and well-being of older people. From an economic perspective, the cost of medical care related to falls and resulting injuries is very high and continue to grow with the aging of the population. Therefore falls prevention is a public health priority.
Many data suggest that cognitive, common disorders in the elderly, is a major risk factor for falls and the elderly often have difficulty managing their parallel postural stability and other situations requiring attentional resources. Furthermore, the data used to evoke a role of vitamin D in the risk of falls in the elderly. Indeed, vitamin D has beneficial effects on muscle and on the human brain and several recent studies have shown the existence of positive relationship between serum 25 hydroxyvitamin D and cognitive function. These different actions may explain the beneficial effect of vitamin D supplementation on the risk of falling for practicing daily oral doses of vitamin D in the range of 700-1000 IU.
Read more
Our goal in this study is to confirm the existence of a link between vitamin D status and some areas of cognitive functions, and analyze the roles played by vitamin D deficiency and cognitive impairment in the occurrence of falls. The study will also seek the existence of a threshold level of 25-hydroxyvitamin D below which may arise cognitive disorders. The prospective follow-up of patients for 2 years will study the effect of correcting the vitamin D deficiency (initial correction and regular supplementation) on cognitive function, balance, walking and the occurrence of falls.
The study will be conducted in 150 subjects aged 50 years and over and fell in 150 subjects aged 50 and over at risk of falling. These patients will be enrolled in the Emergency Services, Orthopedics, Geriatrics, and Rheumatology of the University Hospital of Caen. All subjects will receive a dose of 25 hydroxyvitamin D, a comprehensive study of cognitive function, tests of balance and walking and assessment of activities of daily living and depression. All the examinations and tests will be carried out during the same half day. According to current recommendations, it will be prescribed a treatment with Vitamin D to subjects with a lowered rate of 25 hydroxyvitamin D (<30 ng / ml) to normalize the rate and will be advised doctors to prescribe regular supplementation vitamin D in order to maintain it in the standard rate (30 to 80 ng / ml). The effect of the correction of hypovitaminosis D, confirmed by controlling the rate of 25 hydroxyvitamin D, on cognitive functions, balance and walking will be analyzed 3 months and 9 months. During the two years following their inclusion in the study, subjects will be contacted by a phone call every 3 months during which will be recorded any falls they have been victims, as well as changes to their drug treatments, particularly case of regular intake of vitamin D supplementation.
If our hypothesis were true, it would be appropriate to consider a new approach to prevention of fractures involving the correction of vitamin D deficiency, cognitive rehabilitation and cognitive-motor drive in subjects with cognitive impairment.
- Conditions
- Accidental Falls
- Being tested
- Measurement of serum 25-hydroxyvitamin D, Analysis of global cognitive efficiency score assessed by the "Montreal Cognitive Assessment" (MoCA).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of serum 25-hydroxyvitamin DOther
Analysis of global cognitive efficiency score assessed by the "Montreal Cognitive Assessment" (MoCA).Other
| Study group | Role | What they receive |
|---|---|---|
| Fallers | patients aged 50 years and over who already fell Receives: Other: Measurement of serum 25-hydroxyvitamin D; Other: Analysis of global cognitive efficiency score assessed by the "Montreal Cognitive Assessment" (MoCA). | |
| At risk of falls | patients aged 50 years and over at risk of falls Receives: Other: Measurement of serum 25-hydroxyvitamin D; Other: Analysis of global cognitive efficiency score assessed by the "Montreal Cognitive Assessment" (MoCA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25-hydroxyvitamin D
Measured: change over baseline, 3 month, 9 month
"Montreal Cognitive Assessment" (MoCA).
Measured: change over baseline, 3 month, 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startJul 2011
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517164
- Sponsor's protocol ID
- 11-053
- Acronym
- VITADCOG
- Status last verified
- Aug 2015
- First submitted
- 23 Jul 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin D Levels (Serum 25-hydroxyvitamin D) and Cognitive Impairment in the Occurrence of Falls
- ClinicalTrials.gov ID
- NCT02517164
- Acronym / sponsor ID
- VITADCOG / 11-053
- Conditions
- Accidental Falls
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2015 (estimated)
- First posted
- 6 Aug 2015 (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.
Every year, nearly 30% of people aged over 65 fall at least once and about 15% fall at least twice. These falls can have serious consequences that are a significant threat to the independence and well-being of older people. From an economic perspective, the cost of medical care related to falls and resulting injuries is very high and continue to grow with the aging of the population. Therefore falls prevention is a public health priority.
Many data suggest that cognitive, common disorders in the elderly, is a major risk factor for falls and the elderly often have difficulty managing their parallel postural stability and other situations requiring attentional resources. Furthermore, the data used to evoke a role of vitamin D in the risk of falls in the elderly. Indeed, vitamin D has beneficial effects on muscle and on the human brain and several recent studies have shown the existence of positive relationship between serum 25 hydroxyvitamin D and cognitive function. These different actions may explain the beneficial effect of vitamin D supplementation on the risk of falling for practicing daily oral doses of vitamin D in the range of 700-1000 IU.
Our goal in this study is to confirm the existence of a link between vitamin D status and some areas of cognitive functions, and analyze the roles played by vitamin D deficiency and cognitive impairment in the occurrence of falls. The study will also seek the existence of a threshold level of 25-hydroxyvitamin D below which may arise cognitive disorders. The prospective follow-up of patients for 2 years will study the effect of correcting the vitamin D deficiency (initial correction and regular supplementation) on cognitive function, balance, walking and the occurrence of falls.
The study will be conducted in 150 subjects aged 50 years and over and fell in 150 subjects aged 50 and over at risk of falling. These patients will be enrolled in the Emergency Services, Orthopedics, Geriatrics, and Rheumatology of the University Hospital of Caen. All subjects will receive a dose of 25 hydroxyvitamin D, a comprehensive study of cognitive function, tests of balance and walking and assessment of activities of daily living and depression. All the examinations and tests will be carried out during the same half day. According to current recommendations, it will be prescribed a treatment with Vitamin D to subjects with a lowered rate of 25 hydroxyvitamin D (<30 ng / ml) to normalize the rate and will be advised doctors to prescribe regular supplementation vitamin D in order to maintain it in the standard rate (30 to 80 ng / ml). The effect of the correction of hypovitaminosis D, confirmed by controlling the rate of 25 hydroxyvitamin D, on cognitive functions, balance and walking will be analyzed 3 months and 9 months. During the two years following their inclusion in the study, subjects will be contacted by a phone call every 3 months during which will be recorded any falls they have been victims, as well as changes to their drug treatments, particularly case of regular intake of vitamin D supplementation.
If our hypothesis were true, it would be appropriate to consider a new approach to prevention of fractures involving the correction of vitamin D deficiency, cognitive rehabilitation and cognitive-motor drive in subjects with cognitive impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fallers | – | Other: Measurement of serum 25-hydroxyvitamin D, Other: Analysis of global cognitive efficiency score assessed by the "Montreal Cognitive Assessment" (MoCA).patients aged 50 years and over who already fell |
| At risk of falls | – | Other: Measurement of serum 25-hydroxyvitamin D, Other: Analysis of global cognitive efficiency score assessed by the "Montreal Cognitive Assessment" (MoCA).patients aged 50 years and over at risk of falls |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fallers and person at risk of falls aged at least 50 years
Key inclusion criteria (4 listed)
- Male or female patient, aged at least 50 years;
- Patient able to walk only 15 m, possibly helped by wearing a cane;
- For those aged 50 and over and having fallen: the victim of a fall from a height of uncomplicated fracture in the last 12 months; the fall occurred while standing, or walking, or from the sitting position;
- For those aged 50 and over at risk of falling: woman aged 75 and over, or about having one or more predisposing factors for falls, such as trouble walking or balance (test score the "timed up and got" ≥ 14 sec, muscle weakness of the lower limbs (≤ 4/5), visual disturbance (scale "Monoyer"; corrected visual acuity <10/20 for the sum of the two eyes), impaired lower limb proprioception (position sense test toes), depression (justifying drug therapy), cognitive disorders (MMS ≤ 26), parkinsonism (known diagnosis and clinical examination), osteoarthritis disrupting travel (known diagnosis and clinical and radiographic examinations), subject taking more than 4 drugs per day, taking psychotropic drugs.
Key exclusion criteria (14 listed)
- The subject is a person deprived of liberty or an adult placed under guardianship;
- The inclusion of the subject in another biomedical research protocol for this study (unless prior approval of the principal investigator);
- The subject can walk only with the help of a third person or with the help of two canes or a walker;
- The subject is suffering from severe or progressive neurological condition;
- The subject has severe cognitive impairment (MMS <20)
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 |
|---|---|---|
| Measurement of serum 25-hydroxyvitamin D | Other | At risk of falls, Fallers |
| Analysis of global cognitive efficiency score assessed by the "Montreal Cognitive Assessment" (MoCA). | Other | At risk of falls, Fallers |
Primary outcome
Serum 25-hydroxyvitamin D
Time frame: change over baseline, 3 month, 9 month
"Montreal Cognitive Assessment" (MoCA).
Time frame: change over baseline, 3 month, 9 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Falls, run by University Hospital, Caen 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 4 inclusion and 14 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 6 Aug 2015. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25-hydroxyvitamin D (time frame: change over baseline, 3 month, 9 month). The study lists 2 primary outcomes in all. 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 6 Aug 2015.