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:
Avera McKennan Hospital & University Health Center
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
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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 May 16, 2013