Iron & Vitamin C Study

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881803
• Other study ID #: B4162C-6
• Status: Completed
• Phase: N/A
• First received: March 25, 2009
• Last updated: May 21, 2012
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
United States	VA Medical Center, Bronx	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No