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The investigators' previous work in males with Becker Muscular Dystrophy shows that functional sympatholysis is restored by acute inorganic nitrate supplementation. This was translated from work using the mdx mouse model of dystrophinopathy. Recent work has shown that there is a frank improvement in grip strength when mdx mice are treated with an inorganic Nitric Oxide (NO) donor. The purpose of this study is to determine if chronic treatment with an inorganic NO donor can benefit patients with muscular dystrophy beyond blood flow regulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Nitrate (Beetroot Juice) | Experimental | Sodium nitrate in the form of beetroot juice will be administered orally. Patients will be assessed with a number of functional muscle assessments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Nitrate | Drug | Patients will be given sodium nitrate daily in the form of beetroot juice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in maximal handgrip strength | Change from baseline in handgrip strength at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle function - Performance of Upper Limb Scale | Change in functional muscle assessment as measured by the Performance of Upper Limb Scale | Change from baseline in muscle function - the Performance of Upper Limb Scale at 3 months |
| Change in muscle tissue markers - histology and proteomics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald G Victor, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C031618 | sodium nitrate |
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Change in tissue markers such as neuronal Nitric Oxide Synthase (nNOS) content and location and nitrosative stress by histology and proteomics |
| Change from baseline in muscle tissue markers at 3 monthss |
| Change in systolic wall strain - imaging | Change in the cardiac wall strain as measured by Cardiac Magnetic Resonance Imaging | Change from baseline in cardiac systolic wall strain at 3 months |
| Change in muscle function - North Star Ambulatory Assessment | Change in functional muscle assessment as measured by the North Star Ambulatory Assessment | Change from baseline in muscle function - North Star Ambulatory Assessment at 3 months |
| Change in muscle function - 6 minute walk test | Change in functional muscle assessment as measured by the 6 minute walk test | Change from baseline in muscle function - 6 minute walk test at 3 months |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |