Iron & Vitamin C Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00881803

Enrollment

Registered

2009-04-15

Start date

2008-06-30

Completion date

2011-06-30

Last updated

2012-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injuries, Ascorbic Acid, Vitamin C, Iron, Dietary Supplements

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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.

Countries

United States

Outcome results