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

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Sports Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Matthew Vukovich, PhD, South Dakota State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 4, 2011

First Posted (Estimate)

April 5, 2011

Study Record Updates

Last Update Posted (Estimate)

August 25, 2014

Last Update Submitted That Met QC Criteria

August 22, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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