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Completed

NCT Number: NCT01328704

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

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.

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Key information

Conditions

Anemia Avitaminosis Deficiency Diseases Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Avera Sports Institute

Sioux Falls, South Dakota, 57105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Avera McKennan Hospital & University Health Center

Other

Registry information

Official study title

Observational Study to Evaluate Changes in Iron, Vit-D, and CRP During a Twelve to Twenty-Four Week Supervised Triathlon Training Program

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2011
Registry last updated
Aug 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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