NCT00881803|Completed
Iron & Vitamin C Study
Implications of Concurrent Iron and Ascorbic Acid Supplementation on Iron Status in Persons With Spinal Cord Injury
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Implications of Concurrent Iron and Ascorbic Acid Supplementation on Iron Status in Persons With Spinal Cord Injury
Sponsor study identifier
observational
60
1 country
1
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
June 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
March 25, 2009
Actual (reported)April 15, 2009
Actual (reported)December 2010
Actual (reported)June 2011
Actual (reported)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
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.
Ascorbic Acid Supplementation Only
Iron Supplementation Only
Concurrent Ascorbic Acid \& Iron Supplementation
US Veterans with spinal cord injuries greater than 6 months who are located near Bronx, NY
VA Medical Center, Bronx
The Bronx, New York, 10468, United States
Blood samples will be obtained for analysis.
William Bauman, MD
VA Medical Center, Bronx
First Submitted
March 25, 2009
First Posted
April 15, 2009
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Feasibility Study for the Use of Low-magnitude, High Frequency Mechanical Stimulation of Bone in Persons With Spinal Cord Injury (SCI)
Contact the study team to confirm eligibility.
Study Completion
June 2011
Actual (reported)Last Updated
May 23, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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