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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02147639
Date of registration: 25/03/2014
Prospective Registration: No
Primary sponsor: Cedars-Sinai Medical Center
Public title: Effects of Sodium Nitrate on Blood Flow in Becker Muscular Dystrophy
Scientific title:
Date of first enrolment: October 2013
Target sample size: 19
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02147639
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  Phase 2/Phase 3
Countries of recruitment
United States
Contacts
Name:     Ronald G Victor, MD
Address: 
Telephone:
Email:
Affiliation:  Cedars-Sinai Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

- Men 15-55 years of age with a pre-existing diagnosis of Becker Muscular Dystrophy by a
clinical neurologist (based on clinical criteria plus previous muscle biopsy analysis
and/or DNA analysis).

Exclusion Criteria:

- Any evidence of cardiopulmonary disease by history or by physical examination

- History of hypertension or blood pressure averaging =140/90 mmHg

- Diabetes mellitus or other systemic illness

- Heart failure by clinical exam, elevated BNP, or heart failure medication

- Serum creatinine = 1.5 mg/dL

- Any history of substance abuse (including alcohol)

- Any history of psychiatric illness



Age minimum: 15 Years
Age maximum: 45 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Becker Muscular Dystrophy
Intervention(s)
Dietary Supplement: Placebo
Dietary Supplement: Sodium Nitrate
Dietary Supplement: Sodium Nitrate - double dose
Procedure: Increased exercise intensity
Primary Outcome(s)
Skeletal muscle blood flow [Time Frame: 24 hours after initial visit]
Secondary Outcome(s)
Secondary ID(s)
NANO3
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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