Iron & Vitamin C Study

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT00881803
• Lead Sponsor: US Department of Veterans Affairs

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Primary Completion: 2010-12
• Study Completion: 2011-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-21
• Last Update Posted: 2012-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

VA Medical Center, Bronx; 🇺🇸 Bronx, New York, United States