What does Craig Good think of multivitamins
Plus epicatechin Duchenne muscular dystrophy in non-ambulatory adolescents
- Age 8 to 17 years
- Not outpatient (10 m running / walking for less than 10 s not possible)
- Weight = 100 kg
- Diagnosis of DMD confirmed by at least one of the following:
- Dystrophin immunofluorescence and / or immunoblot with complete dystrophin deficiency and clinical picture consistent with typical DMD or
- Gene deletions test positive (without one or more exons) of the dystrophin gene. The reading frame can be predicted as "out of frame" and as a clinical picture consistent with typical DMD or
- Complete dystrophin gene sequencing with changes (point mutation, duplication or other mutation that leads to a stop codon mutation) that can be definitely associated with DMD, with a typical clinical picture of DMD, or
- Positive family history of DMD, confirmed by one of the criteria listed in a above, siblings or uncle on the mother's side and a clinical picture typical of DMD.
- Cardiac ejection fraction> 55% on the echocardiogram
- Use of dietary supplements, herbs, and antioxidants with the intent to maintain or improve skeletal muscle strength or functional mobility was discontinued at least 4 weeks prior to screening (daily multivitamin use is acceptable).
- Glucocorticoid therapy, if used, must have a stable weight-based dose of at least 3 months prior to enrollment
Cardiac therapy, if used, includes prophylactic ACE inhibitors, aldosterone receptor antagonists (e.g.
Spironolactone, eplerenone etc.) and / or beta blocker therapy and must be stable for 3 months prior to enrollment.
- Hematology profile in the normal range.
- Basic profile of laboratory safety chemistry in the typical range for DMD (elevated) ALT / AST acceptable in the absence of elevated GGT, elevated CK acceptable).
- Inability to perform heart or strength, range of motion, and mobility assessments per protocol
- Currently enrolled in another clinical treatment study.
- History of significant comorbidities or significant impairment of kidney or kidney disease, liver function.
- Use of regular daily aspirin or other antiplatelet drugs within 3 weeks of the first dose of study medication.
- Cardiac symptoms that the investigator believes may indicate impending moderate to severe cardiac events, regardless of LVEF.
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