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

Completed

• Conditions: Vitamin D Deficiency; Anemia

• Registration Number: NCT01328704
• Lead Sponsor: Avera McKennan Hospital & University Health Center

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.

Study Timeline

• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-05
• Study Start: 2012-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-22
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hemoglobin level	Baseline, 3 months, 6 months	Serum hemoglobin level
Ferritin level	Baseline, 3 months, 6 months	Serum ferritin level
Hematocrit	Baseline, 3 months, 6 months	Serum hematocrit level
Total Iron Binding Capacity level	Baseline, 3 months, 6 months	Serum TBC level

Trial Locations

Locations (1)

Avera Sports Institute; 🇺🇸 Sioux Falls, South Dakota, United States