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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: |
NCT03995810 |
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Date of registration:
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18/06/2019 |
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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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Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis
CARMUS |
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Scientific title:
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Oral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple Sclerosis |
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Date of first enrolment:
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June 15, 2019 |
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Target sample size:
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3 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03995810 |
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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: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Serbia
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Contacts
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Name:
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Sergej Ostojic, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Novi Sad |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age = 18 years
- Body mass index 19 - 30 kg/m2
- Free of major chronic diseases or acute disorders besides MS
- Fulfilled 2017 McDonald Criteria for the diagnosis of MS
Exclusion Criteria:
- Pregnancy
- Psychiatric comorbidity
- Use of dietary supplements within 4 weeks before study commences
- Unwillingness to return for follow-up analysis
- Abnormal values for lab clinical chemistry (> 2 SD)
- Immunotherapy for the past 6 months
- Treated with systemic corticosteroids during the 30 days before study commences
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeks
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Primary Outcome(s)
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Brain carnosine change
[Time Frame: Baseline vs. eight weeks]
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Secondary Outcome(s)
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Change in neuromuscular performance for autonomic dysfunction (Ewing)
[Time Frame: Baseline vs. eight weeks]
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Change in multidimensional fatigue
[Time Frame: Baseline vs. eight weeks]
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Health-related quality of life with SF36 Questionnaire change
[Time Frame: Baseline vs. eight weeks]
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Change in blood clinical chemistry panel
[Time Frame: Baseline vs. eight weeks]
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Secondary ID(s)
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CM-03CS/2019
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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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