Iron & Vitamin C Study

Study Overview
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Brief Summary
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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.

Official Title
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Implications of Concurrent Iron and Ascorbic Acid Supplementation on Iron Status in Persons With Spinal Cord Injury

Conditions
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Spinal Cord Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Acute cardiovascular, pulmonary or renal conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Ascorbic Acid Supplementation Only | |
| Group 2<br>Iron Supplementation Only | |
| Group 3<br>Concurrent Ascorbic Acid & Iron Supplementation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine iron status if supplemented with ascorbic acid (AA) and/or iron compared to supplementation with iron or AA. |  | 1 episode, at least 6 months after consistent ascorbic acid and/or iron supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the prevalence of high iron status if receiving supplementation with both iron and AA compared to supplementation with iron or AA. |  | 1 episode, at least 6 months after consistent ascorbic acid and/or iron supplementation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injuries, Ascorbic Acid, Vitamin C, Iron, Dietary Supplements