Vitamin D DeficiencyPhase 2DcogNCT03019120
Vitamin D Supplementation and Neurocognition
A Phase 2 study testing Vitamin D in people with Vitamin D Deficiency and Neurocognitive Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
This study will evaluate the effect of vitamin D supplementation on the neurocognitive function of older people with lower than normal levels of vitamin D at baseline Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vitamin D Deficiency, Neurocognitive Dysfunction
- 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
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jan 2017to 24 Feb 2020
- Phase
- Phase 2
- 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 supplements containing vitamin D.
- Normal cognitive function as determined by MoCA Test screening and clinical assessment
- Adequate literacy to enable the performance of cognitive 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
- A diagnosis of dementia
- Taking supplements containing Vitamin D
- 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: The Effect of Vitamin D Supplementation on Neurocognitive Function in Older Subjects
This study will evaluate the effect of vitamin D supplementation on the neurocognitive function of older people with lower than normal levels of vitamin D at baseline
Read the detailed description
Background: Ageing is associated with an increased risk of cognitive decline. 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 cognitive function of older people. The investigators propose a pilot study to evaluate the effect of vitamin D supplementation on the neurocognitive function of older people.
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 included in the study. Exclusion criteria will include any unstable medical condition as determined by the treating physician, a diagnosis of dementia, 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 the performance of computerized neurocognitive testing. Following provision of written informed consent for inclusion in the study, subjects will answer a questionnaire providing demographic details, undergo cognitive screening by use of the MoCA test, and computerized cognitive assessment using the Neurotrax battery. 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. Levels of serum calcium will be repeated monthly (end of month 1, 2, 3). At 3 months subjects will undergo repeat testing for level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax battery.
- Conditions
- Vitamin D Deficiency, Neurocognitive Dysfunction
- Being tested
- Vitamin D
- Medical subject headings
- Vitamin D Deficiency, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
- Subjects will undergo a cognitive evaluation using the Montreal Cognitive Assessment (MoCA) screening test and the Neurotrax computerized cognitive assessment battery.
- Subjects will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months.
- Levels of serum calcium will be repeated monthly (end of month 1, 2, 3).
- Subjects 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 subjects will be asked to complete the Neurotrax computerized cognitive assessment battery.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Intervention group | Experimental | Vitamin D supplementation for subjects with below normal levels of this vitamin. Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function as assessed by the Neurotrax computerized cognitive assessment battery
The Neurotrax computerized cognitive assessment instrument measures the following domains: Memory, executive functions, attention, verbal functions and motor skills. This instrument was found to have high validity in identifying patients who suffer from cognitive decline in comparison to healthy patients in the elderly. There are many advantages to a computerized cognitive assessment tool. It allows a measurement of various cognitive domains as well as an accurate, detailed and objective measurements of patients. It is also very sensitive to cognitive changes occurring in a specific individual over time.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start15 Jan 2017
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Why it stopped: Due to administrative reasons, it was not possible to enroll subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzvi Dwolatzky, Rambam Health Care Campus
- Investigators
- Elad Rubin, M.A, Study director, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019120
- Sponsor's protocol ID
- 0103-16-LND
- Acronym
- Dcog
- Status last verified
- Feb 2020
- First submitted
- 9 Jan 2017
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Annweiler C, Allali G, Allain P, Bridenbaugh S, Schott AM, Kressig RW, Beauchet O. Vitamin D and cognitive performance in adults: a systematic review. Eur J Neurol. 2009 Oct;16(10):1083-9. doi: 10.1111/j.1468-1331.2009.02755.x. Epub 2009 Jul 29.
PubMed 19659751Buell JS, Dawson-Hughes B. Vitamin D and neurocognitive dysfunction: preventing "D"ecline? Mol Aspects Med. 2008 Dec;29(6):415-22. doi: 10.1016/j.mam.2008.05.001. Epub 2008 May 13.
PubMed 18579197Dwolatzky T, Whitehead V, Doniger GM, Simon ES, Schweiger A, Jaffe D, Chertkow H. Validity of a novel computerized cognitive battery for mild cognitive impairment. BMC Geriatr. 2003 Nov 2;3:4. doi: 10.1186/1471-2318-3-4.
PubMed 14594456Lifshitz M, Dwolatzky T, Press Y. Validation of the Hebrew version of the MoCA test as a screening instrument for the early detection of mild cognitive impairment in elderly individuals. J Geriatr Psychiatry Neurol. 2012 Sep;25(3):155-61. doi: 10.1177/0891988712457047.
PubMed 23124009
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation on Neurocognitive Function in Older Subjects
- ClinicalTrials.gov ID
- NCT03019120
- Acronym / sponsor ID
- Dcog / 0103-16-LND
- Conditions
- Vitamin D Deficiency, Neurocognitive Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to administrative reasons, it was not possible to enroll subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 12 Jan 2017 (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.
This study will evaluate the effect of vitamin D supplementation on the neurocognitive function of older people with lower than normal levels of vitamin D at baseline
Detailed description
Background: Ageing is associated with an increased risk of cognitive decline. 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 cognitive function of older people. The investigators propose a pilot study to evaluate the effect of vitamin D supplementation on the neurocognitive function of older people.
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 included in the study. Exclusion criteria will include any unstable medical condition as determined by the treating physician, a diagnosis of dementia, 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 the performance of computerized neurocognitive testing. Following provision of written informed consent for inclusion in the study, subjects will answer a questionnaire providing demographic details, undergo cognitive screening by use of the MoCA test, and computerized cognitive assessment using the Neurotrax battery. 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. Levels of serum calcium will be repeated monthly (end of month 1, 2, 3). At 3 months subjects will undergo repeat testing for level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax battery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Intervention group | Experimental | Drug: Vitamin DVitamin D supplementation for subjects with below normal levels of this vitamin. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 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 supplements containing vitamin D.
- Normal cognitive function as determined by MoCA Test screening and clinical assessment
Key exclusion criteria (6 listed)
- Age younger than 65 years
- Health status not stable as determined by the treating primary care physician
- A diagnosis of dementia
- Taking supplements containing Vitamin D
- Significant visual or hearing impairment not corrected by spectacles or hearing aids
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 D1. Subjects will undergo a cognitive evaluation using the Montreal Cognitive Assessment (MoCA) screening test and the Neurotrax computerized cognitive assessment battery. 2. Subjects will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months. 3. Levels of serum calcium will be repeated monthly (end of month 1, 2, 3). 4. Subjects will undergo a repeat blood test to examine the level of vitamin D at the end of 3 months of follow-up. 5. At 3-month follow-up subjects will be asked to complete the Neurotrax computerized cognitive assessment battery. | Drug | Active Comparator: Intervention group |
Primary outcome
Change in cognitive function as assessed by the Neurotrax computerized cognitive assessment battery
Time frame: 3 months
The Neurotrax computerized cognitive assessment instrument measures the following domains: Memory, executive functions, attention, verbal functions and motor skills. This instrument was found to have high validity in identifying patients who suffer from cognitive decline in comparison to healthy patients in the elderly. There are many advantages to a computerized cognitive assessment tool. It allows a measurement of various cognitive domains as well as an accurate, detailed and objective measurements of patients. It is also very sensitive to cognitive changes occurring in a specific individual over time.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Background: PubMed 19659751Annweiler C, Allali G, Allain P, Bridenbaugh S, Schott AM, Kressig RW, Beauchet O. Vitamin D and cognitive performance in adults: a systematic review. Eur J Neurol. 2009 Oct;16(10):1083-9. doi: 10.1111/j.1468-1331.2009.02755.x. Epub 2009 Jul 29.
- Background: PubMed 18579197Buell JS, Dawson-Hughes B. Vitamin D and neurocognitive dysfunction: preventing "D"ecline? Mol Aspects Med. 2008 Dec;29(6):415-22. doi: 10.1016/j.mam.2008.05.001. Epub 2008 May 13.
- Background: PubMed 14594456Dwolatzky T, Whitehead V, Doniger GM, Simon ES, Schweiger A, Jaffe D, Chertkow H. Validity of a novel computerized cognitive battery for mild cognitive impairment. BMC Geriatr. 2003 Nov 2;3:4. doi: 10.1186/1471-2318-3-4.
- Background: PubMed 23124009Lifshitz M, Dwolatzky T, Press Y. Validation of the Hebrew version of the MoCA test as a screening instrument for the early detection of mild cognitive impairment in elderly individuals. J Geriatr Psychiatry Neurol. 2012 Sep;25(3):155-61. doi: 10.1177/0891988712457047.
- Individual participant dataSharing planned: No
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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.
Elad Rubin, M.A study director
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D in people with Vitamin D Deficiency and Neurocognitive Dysfunction, run by Rambam Health Care Campus 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 7 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: withdrawn, as of the sponsor's last update on 26 Feb 2020. 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.
What does this 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.
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 was withdrawn before enrolling participants, so there are no results.
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 cognitive function as assessed by the Neurotrax computerized cognitive assessment battery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03019120, which also lists 4 linked publications.
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 26 Feb 2020.