Iron & Vitamin C Study
Completed
Conditions studied: Spinal Cord Injury
In brief
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.
Key facts
- Study ID
- NCT00881803
- Run by
- US Department of Veterans Affairs
- People needed
- 60
- Starts
- 2008-06-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2012-05-23
Who can join
Age: 18 and older, up to 90. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Male
- 18 years to 90 years of age
- Medically stable
- Chronic SCI (>6 months post injury) without regard to the level or completeness of lesion
- 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.
- Veteran
You may not qualify if…
- Acute cardiovascular, pulmonary or renal conditions
Where it is running
- VA Medical Center, Bronx — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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