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:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01328704
First received: April 1, 2011
Last updated: August 22, 2014
Last verified: August 2014
  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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 1, 2011
Last Updated: August 22, 2014
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:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 22, 2014