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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01328704

Enrollment

Registered

2011-04-05

Start date

2012-01-31

Completion date

2013-03-31

Last updated

2014-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Vitamin D Deficiency

Keywords

Iron deficiency, Vitamin D deficiency, Anemia, Athletes, Triathletes, Triathlon

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Iron level	baseline, 3 months, 6 months	Serum iron levels
Vitamin D level	Baseline, 3 months, 6 months	Serum Vitamin D 25(OH)D levels
C-Reactive Protein level	Baseline, 3 months, 6 months	Serum C-reactive protein level

Secondary

Measure	Time frame	Description
Ferritin level	Baseline, 3 months, 6 months	Serum ferritin level
Total Iron Binding Capacity level	Baseline, 3 months, 6 months	Serum TBC level
Hemoglobin level	Baseline, 3 months, 6 months	Serum hemoglobin level
Hematocrit	Baseline, 3 months, 6 months	Serum hematocrit level

Countries

United States

Outcome results