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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: |
NCT01952483 |
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Date of registration:
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19/09/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Vitamin D Replacement on Immune Function and Cognition in MS Patients
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Scientific title:
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Effect of Vitamin D Replacement on Immune Function and Cognition in MS Patients |
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Date of first enrolment:
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August 2012 |
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Target sample size:
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108 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01952483 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Samia J Khoury, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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AUBMC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Definite diagnosis of Multiple Sclerosis following the revised McDonald MS diagnostic
criteria
2. Male and Female Aged 18 and above
3. On interferon-ß treatment (Rebif®, Avonex®, or Betaseron®)
4. No signs of active inflammation or attack or new lesions on MRI
Exclusion Criteria:
1. Treatment with immune modulating/ suppressive drugs other than IFN-b within 6 weeks
prior to enrolment
2. Pregnancy
3. Hypercalcemia
4. eglomerular filtration rate<60
5. History of primary hyperparathyroidism, hypercalcemia, renal dysfunction, cardiac
disease, malignancy, or granulomatous disease
6. The occurrence of an exacerbation (defined as an episode of neurologic dysfunction
lasting at least 24 hours) within 4 weeks of enrollment
7. History of dementia or related disorders
8. History of traumatic brain injury
9. Diagnosis of epilepsy or history of seizure
10. Diagnosis of psychiatric disease, substance abuse/dependence, alcohol abuse/dependence
11. Currently, on any of the following medications Lithium, or Thiazide diuretics
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis (MS)
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Primary Outcome(s)
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Is there evidence of immune activation in MS patients deficient in Vitamin D and does Vitamin D supplementation reverse the immune activation?
[Time Frame: 3months]
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Secondary Outcome(s)
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Does Vitamin D deficiency result in lower cognitive performance in MS patients and does Vitamin D supplementation reverse the cognitive impairment?
[Time Frame: 3 months]
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Secondary ID(s)
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IM.SK1.04
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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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