Vitamin D Supplementation and Neurocognition (Dcog)
Primary Purpose
Vitamin D Deficiency, Neurocognitive Dysfunction
Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Laniado Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active Comparator: Intervention group
Arm Description
Vitamin D supplementation for subjects with below normal levels of this vitamin.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03019120
First Posted
January 9, 2017
Last Updated
February 24, 2020
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT03019120
Brief Title
Vitamin D Supplementation and Neurocognition
Acronym
Dcog
Official Title
The Effect of Vitamin D Supplementation on Neurocognitive Function in Older Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Due to administrative reasons, it was not possible to enroll subjects.
Study Start Date
January 15, 2017 (Actual)
Primary Completion Date
February 24, 2020 (Actual)
Study Completion Date
February 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Neurocognitive Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator: Intervention group
Arm Type
Experimental
Arm Description
Vitamin D supplementation for subjects with below normal levels of this vitamin.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in cognitive function as assessed by the Neurotrax computerized cognitive assessment battery
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elad Rubin, M.A
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Director
Facility Information:
Facility Name
Laniado Medical Center
City
Netanya
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19659751
Citation
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.
Results Reference
background
PubMed Identifier
18579197
Citation
Buell 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.
Results Reference
background
PubMed Identifier
14594456
Citation
Dwolatzky 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.
Results Reference
background
PubMed Identifier
23124009
Citation
Lifshitz 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.
Results Reference
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Vitamin D Supplementation and Neurocognition
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