Iron & Vitamin C Study

NCT00881803 | Completed

• 1 other identifier: B4162C-6
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (3)

Group 1

Ascorbic Acid Supplementation Only

Group 2

Iron Supplementation Only

Group 3

Concurrent Ascorbic Acid \& Iron Supplementation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

US Veterans with spinal cord injuries greater than 6 months who are located near Bronx, NY

You may qualify if:

• Male
• 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

You may not qualify if:

• Acute cardiovascular, pulmonary or renal conditions

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained for analysis.

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• William Bauman, MD

  VA Medical Center, Bronx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: April 15, 2009
• Study Start: June 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: May 23, 2012

Record last verified: 2012-05

Locations

US (1)