VITAMIN D DEFICIENCYNCT02381600
An Evaluation of the Effect of Vitamin D Supplementation on the Cognitive Function of Older Subjects With Low Levels of This Vitamin
A study testing Vitamin D in people with VITAMIN D DEFICIENCY, run by Meir Medical Center at 1 site in Israel.
Trial summary
Background: Ageing is associated with an increased risk of cognitive decline and depression. Vitamin D plays an important role in many of the symptoms and conditions related to advanced age, including impaired balance, falls and osteoporosis. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- VITAMIN D DEFICIENCY
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Oct 2016
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adults aged 65 years and older.
- Level of vitamin D (25-OH vitamin D) is less than 30 ng / ml.
- Stable health status as assessed by the treating primary care physician.
- Do not take antidepressant medications.
- Do not take supplements containing vitamin D.
- Normal cognitive function as determined by MoCA Test screening and clinical assessment
- Adequate literacy to enable the performance of assessment instruments
- Provide informed consent as required by the Ethics Committee.
Who cannot join
- Age younger than 65 years
- Health status not stable as determined by the treating primary care physician
- Cognitive impairment or dementia
- Illiteracy
- Taking supplements containing Vitamin D
- Taking antidepressant medications
- Significant visual or hearing impairment not corrected by spectacles or hearing aids
- Impaired competency limiting the subject's ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Effects of Vitamin D Supplementation on Specific Cognitive Functions and Depressive Symptoms of Older Subjects With Low Levels of This Vitamin
Background: Ageing is associated with an increased risk of cognitive decline and depression. Vitamin D plays an important role in many of the symptoms and conditions related to advanced age, including impaired balance, falls and osteoporosis. Vitamin D also has a physiological effect on the function of the central nervous system, and studies have suggested a relationship between this vitamin and changes in affect and cognitive function in the elderly. The investigators propose a pilot study to examine the relationship between below-normal levels of Vitamin D to affective symptoms and specific cognitive functions in the elderly.
Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH Vitamin D lower than 30 ng/ml on routine laboratory screening will be referred by the treating family physicianfor screening. Subjects will be required to provide written informed consent for inclusion in the study. Exclusion criteria will include any active or unstable medical condition as determined by the treating physician, known neurocognitive disorder, known affective disorder, the use of any class of antidepressant drugs, the use of supplements containing vitamin D in any dose, significant visual or hearing impairment not corrected by spectacles or hearing aids, and a level of literacy that limits cognitive ability. All subjects will undergo cognitive screening by use of the MoCA test, computerized cognitive assessment using the the Neurotrax (®Mindstreams) computerised cognitive assessment battery, and the 15-item Geriatric Depression Scale. All subjects will undergo repeat testing for level of 25-OH Vitamin D, and where below-normal levels are confirmed patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months. At 3 months subjects will undergo repeat testing for level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax Mindstreams battery and the 15-item Geriatric Depression Scale (GDS).
Read the detailed description
Background: Ageing is associated with an increased risk of cognitive decline and depression. Vitamin D plays an important role in many of the symptoms and conditions related to advanced age, including impaired balance, falls and osteoporosis. Vitamin D also has a physiological effect on the function of the central nervous system, and studies have suggested a relationship between this vitamin and changes in affect and cognitive function in the elderly. The investigators propose a pilot study to examine the relationship between below-normal levels of Vitamin D to affective symptoms and specific cognitive functions in the elderly.
Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH Vitamin D lower than 30 ng/ml on routine laboratory screening will be referred by the treating family physicianfor screening. Subjects will be required to provide written informed consent for inclusion in the study. Exclusion criteria will include any active or unstable medical condition as determined by the treating physician, known neurocognitive disorder, known affective disorder, the use of any class of antidepressant drugs, the use of supplements containing vitamin D in any dose, significant visual or hearing impairment not corrected by spectacles or hearing aids, and a level of literacy that limits cognitive ability. All subjects will undergo cognitive screening by use of the MoCA test, computerized cognitive assessment using the the Neurotrax (®Mindstreams) computerised cognitive assessment battery, and the 15-item Geriatric Depression Scale. All subjects will undergo repeat testing for level of 25-OH Vitamin D, and where below-normal levels are confirmed patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months. At 3 months subjects will undergo repeat testing for level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax Mindstreams battery and the 15-item Geriatric Depression Scale (GDS).
Study Type: An open-label prospective pilot interventional study
Study Design: the one group pretest-posttest design.
- Conditions
- VITAMIN D DEFICIENCY
- Being tested
- Vitamin D
- Keywords
- vitamin D, aging, cognitive function, depression, executive function
- Medical subject headings
- Vitamin D Deficiency, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Experimental :
- Patients will undergo clinical and functional assessment as well as evaluation using the Montreal Cognitive Assessment (MoCA) screening test, the modified 15-item Geriatric Depression Scale, and the Neurotrax (®Mindstreams) computerised cognitive assessment battery.
- Patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months Patients will undergo a repeat blood test to examine the level of vitamin D at the end of 3 months of follow-up.
- At 3-month follow-up atients will be asked to complete the 15-item GDS and the Neurotrax (®Mindstreams) computerised cognitive assessment battery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group- vitamin D | Experimental | Include patients aged 65 years and older that are found to have below-normal serum levels of vitamin D on routine laboratory testing. After providing informed consent (the study was submitted for approval by the Ethics Committee of the Clalit Health Services) eligible subjects will undergo cognitive and affective assessment Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function as assessed by the Neurotrax (®Mindstreams) computerised cognitive assessment battery
Change in cognitive function at 3 months compared to baseline according to cognitive indices on a computerized assessment battery
Measured: Baseline and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Difficulties recruiting participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VITAMIN D DEFICIENCYStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381600
- Sponsor's protocol ID
- ק096/2014
- Status last verified
- Oct 2016
- First submitted
- 8 Feb 2015
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effects of Vitamin D Supplementation on Specific Cognitive Functions and Depressive Symptoms of Older Subjects With Low Levels of This Vitamin
- ClinicalTrials.gov ID
- NCT02381600
- Acronym / sponsor ID
- ק096/2014
- Conditions
- VITAMIN D DEFICIENCY
- Keywords
- vitamin D, aging, cognitive function, depression, executive function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties recruiting participant
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 Mar 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.
Background: Ageing is associated with an increased risk of cognitive decline and depression. Vitamin D plays an important role in many of the symptoms and conditions related to advanced age, including impaired balance, falls and osteoporosis. Vitamin D also has a physiological effect on the function of the central nervous system, and studies have suggested a relationship between this vitamin and changes in affect and cognitive function in the elderly. The investigators propose a pilot study to examine the relationship between below-normal levels of Vitamin D to affective symptoms and specific cognitive functions in the elderly.
Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH Vitamin D lower than 30 ng/ml on routine laboratory screening will be referred by the treating family physicianfor screening. Subjects will be required to provide written informed consent for inclusion in the study. Exclusion criteria will include any active or unstable medical condition as determined by the treating physician, known neurocognitive disorder, known affective disorder, the use of any class of antidepressant drugs, the use of supplements containing vitamin D in any dose, significant visual or hearing impairment not corrected by spectacles or hearing aids, and a level of literacy that limits cognitive ability. All subjects will undergo cognitive screening by use of the MoCA test, computerized cognitive assessment using the the Neurotrax (®Mindstreams) computerised cognitive assessment battery, and the 15-item Geriatric Depression Scale. All subjects will undergo repeat testing for level of 25-OH Vitamin D, and where below-normal levels are confirmed patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months. At 3 months subjects will undergo repeat testing for level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax Mindstreams battery and the 15-item Geriatric Depression Scale (GDS).
Detailed description
Background: Ageing is associated with an increased risk of cognitive decline and depression. Vitamin D plays an important role in many of the symptoms and conditions related to advanced age, including impaired balance, falls and osteoporosis. Vitamin D also has a physiological effect on the function of the central nervous system, and studies have suggested a relationship between this vitamin and changes in affect and cognitive function in the elderly. The investigators propose a pilot study to examine the relationship between below-normal levels of Vitamin D to affective symptoms and specific cognitive functions in the elderly.
Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH Vitamin D lower than 30 ng/ml on routine laboratory screening will be referred by the treating family physicianfor screening. Subjects will be required to provide written informed consent for inclusion in the study. Exclusion criteria will include any active or unstable medical condition as determined by the treating physician, known neurocognitive disorder, known affective disorder, the use of any class of antidepressant drugs, the use of supplements containing vitamin D in any dose, significant visual or hearing impairment not corrected by spectacles or hearing aids, and a level of literacy that limits cognitive ability. All subjects will undergo cognitive screening by use of the MoCA test, computerized cognitive assessment using the the Neurotrax (®Mindstreams) computerised cognitive assessment battery, and the 15-item Geriatric Depression Scale. All subjects will undergo repeat testing for level of 25-OH Vitamin D, and where below-normal levels are confirmed patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months. At 3 months subjects will undergo repeat testing for level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax Mindstreams battery and the 15-item Geriatric Depression Scale (GDS).
Study Type: An open-label prospective pilot interventional study
Study Design: the one group pretest-posttest design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group- vitamin D | Experimental | Drug: Vitamin DInclude patients aged 65 years and older that are found to have below-normal serum levels of vitamin D on routine laboratory testing. After providing informed consent (the study was submitted for approval by the Ethics Committee of the Clalit Health Services) eligible subjects will undergo cognitive and affective assessment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Adults aged 65 years and older.
- Level of vitamin D (25-OH vitamin D) is less than 30 ng / ml.
- Stable health status as assessed by the treating primary care physician.
- Do not take antidepressant medications.
- Do not take supplements containing vitamin D.
Key exclusion criteria (8 listed)
- Age younger than 65 years
- Health status not stable as determined by the treating primary care physician
- Cognitive impairment or dementia
- Illiteracy
- Taking supplements containing Vitamin D
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 |
|---|---|---|
| Vitamin DExperimental : 1. Patients will undergo clinical and functional assessment as well as evaluation using the Montreal Cognitive Assessment (MoCA) screening test, the modified 15-item Geriatric Depression Scale, and the Neurotrax (®Mindstreams) computerised cognitive assessment battery. 2. Patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months Patients will undergo a repeat blood test to examine the level of vitamin D at the end of 3 months of follow-up. 3. At 3-month follow-up atients will be asked to complete the 15-item GDS and the Neurotrax (®Mindstreams) computerised cognitive assessment battery. | Drug | Intervention group- vitamin D |
Primary outcome
Cognitive function as assessed by the Neurotrax (®Mindstreams) computerised cognitive assessment battery
Time frame: Baseline and 3-month follow-up
Change in cognitive function at 3 months compared to baseline according to cognitive indices on a computerized assessment battery
Results and safety
The study was stopped early (reason given: Difficulties recruiting participant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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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.
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 study testing Vitamin D in people with VITAMIN D DEFICIENCY, run by Meir Medical Center at 1 site in Israel.
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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 Feb 2021. 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 Israel. 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?
The study was stopped early (reason given: Difficulties recruiting participant). 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?
Cognitive function as assessed by the Neurotrax (®Mindstreams) computerised cognitive assessment battery (time frame: Baseline and 3-month follow-up). 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 25 Feb 2021.