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

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ClinicalTrials.gov Identifier: NCT01328704
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Anemia Vitamin D Deficiency

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
Estimated Enrollment : 50 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

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



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

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

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


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

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

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

  4. 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.


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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

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

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 Posted: April 5, 2011    Key Record Dates
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