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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328704
First Posted: April 5, 2011
Last Update Posted: August 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
  Purpose
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.

Condition
Anemia Vitamin D Deficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study to Evaluate Changes in Iron, Vit-D, and CRP During a Twelve to Twenty-Four Week Supervised Triathlon Training Program

Resource links provided by NLM:


Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome Measures:
  • Iron level [ Time Frame: baseline, 3 months, 6 months ]
    Serum iron levels

  • Vitamin D level [ Time Frame: Baseline, 3 months, 6 months ]
    Serum Vitamin D 25(OH)D levels

  • C-Reactive Protein level [ Time Frame: Baseline, 3 months, 6 months ]
    Serum C-reactive protein level


Secondary Outcome Measures:
  • Ferritin level [ Time Frame: Baseline, 3 months, 6 months ]
    Serum ferritin level

  • Hemoglobin level [ Time Frame: Baseline, 3 months, 6 months ]
    Serum hemoglobin level

  • Hematocrit [ Time Frame: Baseline, 3 months, 6 months ]
    Serum hematocrit level

  • Total Iron Binding Capacity level [ Time Frame: Baseline, 3 months, 6 months ]
    Serum TBC level


Biospecimen Retention:   Samples Without DNA
Blood samples will be obtained three times throughout the course of the subject's involvement in the study: baseline, 3 months, and 6 months.

Estimated Enrollment: 50
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Triathletes
Group of individuals who are participating in a triathlon training program at the Avera Sports Institute

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328704


Locations
United States, South Dakota
Avera Sports Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
Principal Investigator: Matthew Vukovich, PhD South Dakota State University
  More Information

Additional Information:
Publications:
Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT01328704     History of Changes
Other Study ID Numbers: ARI-1390-Triathletes
First Submitted: April 1, 2011
First Posted: April 5, 2011
Last Update Posted: August 25, 2014
Last Verified: August 2014

Keywords provided by Avera McKennan Hospital & University Health Center:
Iron deficiency
Vitamin D deficiency
Anemia
Athletes
Triathletes
Triathlon

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents