Iron & Vitamin C Study

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Spinal Cord Injury

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT00881803

B4162C-6

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Male

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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