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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: |
NCT01596803 |
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Date of registration:
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05/04/2012 |
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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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Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)
FSHD |
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Scientific title:
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Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by Facioscapulohumeral Dystrophy (FSHD) |
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Date of first enrolment:
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May 1, 2010 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01596803 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- FSHD patients will be recruited on the basis of:
- The number of repeat units (4 to 9)
- FSHD patients with a positive family history for FSHD
- Not confined to a wheelchair
- No smokers
- No associated co-morbidity (cardiac or pulmonary disease, diabetes etc.)
- No Medications or nutritional supplementation (vitamins and/or antioxidants) at
the time of the study
- No HIV positive
Exclusion Criteria:
- No consent form
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Facioscapulohumeral Muscular Dystrophy
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Intervention(s)
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Dietary Supplement: Placebo Vit E Placebo Vit C Zn Se
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Procedure: Taking of blood
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Dietary Supplement: needle biopsy of the vastus lateralis muscle
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Dietary Supplement: Vit C Vit E Zn Se
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Primary Outcome(s)
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Improvement of muscle effort tolerance after antioxidant supplementation
[Time Frame: duration study 3 years]
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Secondary Outcome(s)
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Changes in inflammatory and oxidative stress parameters after antioxidant supplementation
[Time Frame: duration study 3 years]
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Changes in muscular function after antioxidant supplementation
[Time Frame: duration study 3 years]
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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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