- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01328704
Evaluate the Change in Iron, Vitamin D, and C-Reactive Protein Level (CRP) in a 12 to 24 Week Period
August 22, 2014 updated by: Avera McKennan Hospital & University Health Center
Observational Study to Evaluate Changes in Iron, Vit-D, and CRP During a Twelve to Twenty-Four Week Supervised Triathlon Training Program
The purpose of this study is to observe changes in iron status and vitamin D status during a 12-24 week supervised training program, specifically males and females between the ages of 30 and 50 years old.
Study Overview
Status
Completed
Conditions
Detailed Description
Study subjects will be participants in a triathlon training program through the Avera Sports Institute in Sioux Falls, SD.
This clinical study will examine changes in iron and vitamin D levels.
Blood specimens will be collected at baseline and again after 3 and 6 months of participating in the training program.
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Avera Sports Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Men and pre-menopausal women between the ages of 30 and 50 who are participating in the Triathlon Training Program through the Avera Sports Institute
Description
Inclusion Criteria:
- Males and premenopausal females between the ages of 30 and 50 years old
- Training through the Avera Sports Institute Triathlon Training Program
- Agree to keep diet, exercise and all current health habits stable during participation in the study
Exclusion Criteria:
- Women who are pregnant, breastfeeding or planning to become pregnant
- Has a chronic disease that affects calcium or bone metabolism
- Has a chronic disease that affects iron metabolism or iron storage
- Has kidney disease
- Has any laboratory or biometric value that would indicate an issue for the safety of the study subject
- Is currently participating in another clinical research study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Triathletes
Group of individuals who are participating in a triathlon training program at the Avera Sports Institute
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Iron level
Time Frame: baseline, 3 months, 6 months
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Serum iron levels
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baseline, 3 months, 6 months
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Vitamin D level
Time Frame: Baseline, 3 months, 6 months
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Serum Vitamin D 25(OH)D levels
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Baseline, 3 months, 6 months
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C-Reactive Protein level
Time Frame: Baseline, 3 months, 6 months
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Serum C-reactive protein level
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Baseline, 3 months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ferritin level
Time Frame: Baseline, 3 months, 6 months
|
Serum ferritin level
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Baseline, 3 months, 6 months
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Hemoglobin level
Time Frame: Baseline, 3 months, 6 months
|
Serum hemoglobin level
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Baseline, 3 months, 6 months
|
Hematocrit
Time Frame: Baseline, 3 months, 6 months
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Serum hematocrit level
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Baseline, 3 months, 6 months
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Total Iron Binding Capacity level
Time Frame: Baseline, 3 months, 6 months
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Serum TBC level
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Baseline, 3 months, 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Matthew Vukovich, PhD, South Dakota State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gropper SS, Bader-Crowe DM, McAnulty LS, White BD, Keith RE. Non-anemic iron depletion, oral iron supplementation and indices of copper status in college-aged females. J Am Coll Nutr. 2002 Dec;21(6):545-52. doi: 10.1080/07315724.2002.10719253.
- Kelley GA, Kelley KS. Effects of aerobic exercise on C-reactive protein, body composition, and maximum oxygen consumption in adults: a meta-analysis of randomized controlled trials. Metabolism. 2006 Nov;55(11):1500-7. doi: 10.1016/j.metabol.2006.06.021.
- Malczewska J, Raczynski G, Stupnicki R. Iron status in female endurance athletes and in non-athletes. Int J Sport Nutr Exerc Metab. 2000 Sep;10(3):260-276. doi: 10.1123/ijsnem.10.3.260.
- Newhouse IJ, Clement DB. Iron status in athletes. An update. Sports Med. 1988 Jun;5(6):337-52. doi: 10.2165/00007256-198805060-00001.
- Okita K, Nishijima H, Murakami T, Nagai T, Morita N, Yonezawa K, Iizuka K, Kawaguchi H, Kitabatake A. Can exercise training with weight loss lower serum C-reactive protein levels? Arterioscler Thromb Vasc Biol. 2004 Oct;24(10):1868-73. doi: 10.1161/01.ATV.0000140199.14930.32. Epub 2004 Jul 29.
- Stewart LK, Flynn MG, Campbell WW, Craig BA, Robinson JP, Timmerman KL, McFarlin BK, Coen PM, Talbert E. The influence of exercise training on inflammatory cytokines and C-reactive protein. Med Sci Sports Exerc. 2007 Oct;39(10):1714-9. doi: 10.1249/mss.0b013e31811ece1c.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
April 1, 2011
First Submitted That Met QC Criteria
April 4, 2011
First Posted (Estimate)
April 5, 2011
Study Record Updates
Last Update Posted (Estimate)
August 25, 2014
Last Update Submitted That Met QC Criteria
August 22, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARI-1390-Triathletes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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