Iron & Vitamin C Study

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00881803

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Ascorbic Acid Supplementation Only
Group 2 Iron Supplementation Only
Group 3 Concurrent Ascorbic Acid & Iron Supplementation

Outcome Measures

Primary Outcome Measures

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

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.