Iron & Vitamin C Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00881803
First received: March 25, 2009
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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
Spinal Cord Injury

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples will be obtained for analysis.


Estimated Enrollment: 60
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Ascorbic Acid Supplementation Only
Group 2
Iron Supplementation Only
Group 3
Concurrent Ascorbic Acid & Iron Supplementation

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881803

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

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00881803     History of Changes
Other Study ID Numbers: B4162C-6
Study First Received: March 25, 2009
Last Updated: May 21, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Spinal Cord Injuries
Ascorbic Acid
Vitamin C
Iron
Dietary Supplements

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

ClinicalTrials.gov processed this record on October 21, 2014