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Iron & Vitamin C Study - NCT00881803-10468(Clinical Trial 284317)



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City:  Bronx
State:  
NY
Zip Code: 10468
Conditions: Spinal Cord Injury
Purpose: Iron overload is a life-threatening condition that can lead to liver disease, cardiac disease, diabetes and arthritis. Simultaneous supplementation with both iron and AA may place individuals with SCI at risk for iron overload as well as oxidative damage by iron-generated free radicals. Both conditions of high and low iron stores may present with common signs and symptoms. Accurate diagnosis of iron disorder should consider CRP, hematocrit, hemoglobin, serum iron, TIBC, percent saturation of iron binding capacity, serum ferritin and hepcidin. The investigators are proposing a study to determine the effect of concurrent AA and iron supplementation on iron status of individuals with SCI. The investigators goal is to identify abnormal status that may be attributed to simultaneous supplementation of iron and AA to develop future supplementation protocols in this population for optimal iron status.
Study summary:
Criteria: Inclusion Criteria: 1. Male 2. 18 years to 90 years of age 3. Medically stable 4. Chronic SCI (>6 months post injury) without regard to the level or completeness of lesion 5. Supplementation with: - A standard recommended dose of 120-200 mg oral elemental iron (tablet or liquid; ferrous sulfate, fumarate or gluconate forms) for a minimum of 6 months; or - A standard recommended dose of 250-2,000 mg AA per day for a minimum of 6 months; or - Both 120-200 mg oral elemental iron AND 250-2,000 mg AA per day for a minimum of 6 months. 6. Veteran Exclusion Criteria: Acute cardiovascular, pulmonary or renal conditions
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Data Source: ClinicalTrials.gov
Date Processed: August 16, 2010
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