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

Anemia Clinical Trial

Official title:

Observational Study to Evaluate Changes in Iron, Vit-D, and CRP During a Twelve to Twenty-Four Week Supervised Triathlon Training Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328704
• Other study ID #: ARI-1390-Triathletes
• Status: Completed
• Phase: N/A
• First received: April 1, 2011
• Last updated: August 22, 2014
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2014
• Source: Avera McKennan Hospital & University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Vitamin D Deficiency

Locations

Country	Name	City	State
United States	Avera Sports Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Avera McKennan Hospital & University Health Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Newhouse IJ, Clement DB. Iron status in athletes. An update. Sports Med. 1988 Jun;5(6):337-52. Review. — View Citation

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. Epub 2004 Jul 29. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron level	Serum iron levels	baseline, 3 months, 6 months	No
Primary	Vitamin D level	Serum Vitamin D 25(OH)D levels	Baseline, 3 months, 6 months	No
Primary	C-Reactive Protein level	Serum C-reactive protein level	Baseline, 3 months, 6 months	No
Secondary	Ferritin level	Serum ferritin level	Baseline, 3 months, 6 months	No
Secondary	Hemoglobin level	Serum hemoglobin level	Baseline, 3 months, 6 months	No
Secondary	Hematocrit	Serum hematocrit level	Baseline, 3 months, 6 months	No
Secondary	Total Iron Binding Capacity level	Serum TBC level	Baseline, 3 months, 6 months	No

External Links

•   Avera Research Institute website