Evaluate the Change in Iron, Vitamin D, and C-Reactive Protein Level (CRP) in a 12 to 24 Week Period

NCT ID: NCT01328704

Last Updated: 2014-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anemia Vitamin D Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Triathletes

Group of individuals who are participating in a triathlon training program at the Avera Sports Institute

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Avera McKennan Hospital & University Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Vukovich, PhD

Role: PRINCIPAL_INVESTIGATOR

South Dakota State University

Locations

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Avera Sports Institute

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12480800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17046553 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11183845 (View on PubMed)

Newhouse IJ, Clement DB. Iron status in athletes. An update. Sports Med. 1988 Jun;5(6):337-52. doi: 10.2165/00007256-198805060-00001.

Reference Type BACKGROUND
PMID: 3041528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15284086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17909397 (View on PubMed)

Other Identifiers

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ARI-1390-Triathletes

Identifier Type: -

Identifier Source: org_study_id

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