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Iron & Vitamin C Study

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ClinicalTrials.gov Identifier: NCT00881803
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Spinal Cord Injury

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implications of Concurrent Iron and Ascorbic Acid Supplementation on Iron Status in Persons With Spinal Cord Injury
Study Start Date : June 2008
Primary Completion Date : December 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Group 1
Ascorbic Acid Supplementation Only
Group 2
Iron Supplementation Only
Group 3
Concurrent Ascorbic Acid & Iron Supplementation


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. ]

Biospecimen Retention:   Samples With DNA
Blood samples will be obtained for analysis.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
US Veterans with spinal cord injuries greater than 6 months who are located near Bronx, NY
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881803


Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00881803     History of Changes
Other Study ID Numbers: B4162C-6
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012

Keywords provided by VA Office of Research and Development:
Spinal Cord Injuries
Ascorbic Acid
Vitamin C
Iron
Dietary Supplements

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Iron
Ascorbic Acid
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins