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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03019120 |
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Date of registration:
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09/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Vitamin D Supplementation and Neurocognition
Dcog |
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Scientific title:
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The Effect of Vitamin D Supplementation on Neurocognitive Function in Older Subjects |
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Date of first enrolment:
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January 15, 2017 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT03019120 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Israel
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Contacts
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Name:
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Elad Rubin, M.A |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rambam Health Care Campus |
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Key inclusion & exclusion criteria
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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
Age minimum:
65 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neurocognitive Dysfunction
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Vitamin D Deficiency
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Intervention(s)
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Drug: Vitamin D
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Primary Outcome(s)
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Change in cognitive function as assessed by the Neurotrax computerized cognitive assessment battery
[Time Frame: 3 months]
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Secondary ID(s)
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0103-16-LND
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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