Spinal Cord InjuryNCT00881803
Iron & Vitamin C Study
An observational study of Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: US Veterans with spinal cord injuries greater than 6 months who are located near Bronx, NY
Who may be able to join
- Male
- 18 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
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- 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
Who cannot join
- Acute cardiovascular, pulmonary or renal conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implications of Concurrent Iron and Ascorbic Acid Supplementation on Iron Status in Persons With Spinal Cord Injury
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
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Ascorbic Acid Supplementation Only | |
| Group 2 | Iron Supplementation Only | |
| Group 3 | Concurrent Ascorbic Acid \& Iron Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine iron status if supplemented with ascorbic acid (AA) and/or iron compared to supplementation with iron or AA.
Measured: 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.
Measured: 1 episode, at least 6 months after consistent ascorbic acid and/or iron supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- William Bauman, MD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881803
- Sponsor's protocol ID
- B4162C-6
- Status last verified
- May 2012
- First submitted
- 25 Mar 2009
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Concurrent Iron and Ascorbic Acid Supplementation on Iron Status in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00881803
- Acronym / sponsor ID
- B4162C-6
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injuries, Ascorbic Acid, Vitamin C, Iron, Dietary Supplements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Ascorbic Acid Supplementation Only |
| Group 2 | – | –Iron Supplementation Only |
| Group 3 | – | –Concurrent Ascorbic Acid \& Iron Supplementation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- US Veterans with spinal cord injuries greater than 6 months who are located near Bronx, NY
Key inclusion criteria (9 listed)
- Male
- 18 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:
Key exclusion criteria (1 listed)
- Acute cardiovascular, pulmonary or renal conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Bauman, MD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.