Iron & Vitamin C Study

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

To determine iron status if supplemented with ascorbic acid (AA) and/or iron compared to supplementation with iron or AA.

Time frame: 1 episode, at least 6 months after consistent ascorbic acid and/or iron supplementation

Secondary outcomes

Determine the prevalence of high iron status if receiving supplementation with both iron and AA compared to supplementation with iron or AA.

Time frame: 1 episode, at least 6 months after consistent ascorbic acid and/or iron supplementation.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2011
First posted: Apr 15, 2009
Registry last updated: May 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed