Clinical trial NCT01328704: Evaluate the Change in Iron, Vitamin D, and C-Reactive Protein Level (CRP) in a 12 to 24 Week Period
Official title: Observational Study to Evaluate Changes in Iron, Vit-D, and CRP During a Twelve to Twenty-Four Week Supervised Triathlon Training Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Vitamin D Deficiency
Keywords: Iron deficiency
Vitamin D deficiency
Anemia
Athletes
Triathletes
Triathlon
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Iron level
timeFrame: baseline, 3 months, 6 months
measure: Vitamin D level
timeFrame: Baseline, 3 months, 6 months
measure: C-Reactive Protein level
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Ferritin level
timeFrame: Baseline, 3 months, 6 months
measure: Hemoglobin level
timeFrame: Baseline, 3 months, 6 months
measure: Hematocrit
timeFrame: Baseline, 3 months, 6 months
measure: Total Iron Binding Capacity level
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Sports Institute
state: South Dakota
Study officials:
affiliation: South Dakota State University
name: Matthew Vukovich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/j.metabol.2006.06.021.
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. doi: 10.1123/ijsnem.10.3.260.
citation: Newhouse IJ, Clement DB. Iron status in athletes. An update. Sports Med. 1988 Jun;5(6):337-52. doi: 10.2165/00007256-198805060-00001.
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. doi: 10.1161/01.ATV.0000140199.14930.32. Epub 2004 Jul 29.
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. doi: 10.1249/mss.0b013e31811ece1c.