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

This study is currently recruiting participants.
Verified May 2012 by Avera McKennan Hospital & University Health Center
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01328704
First received: April 1, 2011
Last updated: May 31, 2012
Last verified: May 2012
  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 ] [ Designated as safety issue: No ]
    Serum iron levels

  • Vitamin D level [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Serum Vitamin D 25(OH)D levels

  • C-Reactive Protein level [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Serum C-reactive protein level


Secondary Outcome Measures:
  • Ferritin level [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Serum ferritin level

  • Hemoglobin level [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Serum hemoglobin level

  • Hematocrit [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Serum hematocrit level

  • Total Iron Binding Capacity level [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    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
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (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

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328704

Contacts
Contact: Sarah VanLaecken, EP, MA 605-322-3278 sarah.vanlaecken@avera.org
Contact: Mike Jahnke 605-322-3067 mike.jahnke@avera.org

Locations
United States, South Dakota
Avera Sports Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Sarah VanLaecken, EP, MA    605-322-3278    sarah.vanlaecken@avera.org   
Contact: Mike Jahnke    605-322-3067    mike.jahnke@avera.org   
Sub-Investigator: Sarah VanLaecken, EP, MA         
Sub-Investigator: Derek Ferley, EP, MA         
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
Study First Received: April 1, 2011
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014