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Collegiate Athlete Study

2. Juni 2026 aktualisiert von: Morehouse School of Medicine

Low Energy Availability, Iron Deficiency, Low Vitamin D, and Male and Female Athlete Triad Risk Among Black Collegiate Athletes - A Pilot Study

The purpose of this study is to determine what percentage of Black collegiate athletes have low energy availability. It will also determine the percentage of Black collegiate athletes who have iron deficiency, suboptimal or low Vitamin D levels, and may be at risk for male and female athlete triad. Subsequent to the initial assessment, participants will complete a 12-week iron and vitamin D dietary supplementation protocol according to their baseline iron and vitamin D status.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

A quasi-experimental one group pre-test/post-test design will be utilized in the current investigation among collegiate cross-country and track and field athletes from a Historically Black College and University (HBCU). Members of the men's and women's varsity cross-country teams and track & field teams at this HBCU will be asked to participate in this IRB approved study. Participants who decide to enroll in the study will be asked to sign consent forms.

A 4-question Male Athlete Triad Cumulative Risk Assessment or the 6-question Female Athlete Triad Cumulative Risk Assessment will be completed by each participant.

Participants will have Complete Blood Counts (CBCs), ferritin levels, and Vitamin D levels assessed via blood drawn by phlebotomists. Specimens will be sent to Quest Labs for analysis and results will be uploaded into a secure database.

Athletes will be asked to complete the modified Nutritional/Exercise Survey, which will ask information regarding their daily energy intake, exercise energy expenditure, consumption of macronutrients and food groups, as well as eating patterns, dietary restrictions, and supplement use. The survey will be administered and stored by Qualtrics, a password-protected encrypted platform.

In addition to questions about food intake, each athlete will be asked about the amount and intensity of all aerobic and anerobic exercise they do weekly - including resistance training. Each type of activity will be assigned a specific metabolic equivalent (MET) value. The total MET value per athlete will be based on an athlete's body weight and their total number of exercise hours according to the American College of Sports Medicine's Compendium of Physical Activity.

Participants will meet with a dietitian to further assess their dietary intake, complete a 24-hour dietary recall, and evaluate the athletes' nutrition habits. Information from the dietary consultation, 24-hour recall, and nutrition/exercise survey will be combined to calculate an athlete's risk of energy deficiency.

Athletes will also complete a DEXA scan and undergo an indirect calorimetry assessment. Information from these tests, including the athletes' fat mass, muscle mass, full body Z-score and lumbar spine Z-score (as measures of bone density), and resting metabolic rate will be uploaded into a secure database.

Participants will be given "Calorify Pro Kits" which require them to drink a small sample of doubly labeled water (DLW) then collect 3 urine samples over the course of 1 week, daily weights for 3 weeks, and food intake data. Data from this DLW process, which is currently the gold standard for energy expenditure, will be used to objectively measure energy availability in addition to information collected from dietitians and survey results. All data will be uploaded into a secure database.

Participants will be asked to wear Oura rings on their nondominant hands for 6 weeks initially. Once they return from winter break to start their outdoor season they will be asked to wear the Oura ring for an additional 12 weeks. The Oura rings will track their active vs total caloric expenditure as well as provide ancillary data regarding their sleep effectiveness, basal body temperature, and heart rate.

Once all data have been collected, athletes with iron deficiency or iron deficiency anemia or suboptimal Vitamin D will be notified and given supplements to take daily for 3 months. They will also complete surveys regarding their energy level and quality of life. After 3 months of taking the supplements, the participants will have their blood levels and bone mass reassessed.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

36

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30310
        • Morehouse School of Medicine

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • Members of an HBCU cross-country or track & field team
  • 18 years of age or older
  • Self-identification as Black or African American

Exclusion Criteria:

-Pregnancy

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Determining Nutritional Status and Treating As Needed
Determining energy availability, nutritional status and bone density, then providing iron and vitamin D supplementation as needed.
Nahrungsergänzungsmittel: Iron and Vitamin D Deficiencies Correction

Participants found to be low in Iron and/or Vitamin D will be given supplementation.

Athletes who are classified as having Iron Deficiency will take iron bisglycinate 25mg oral supplements daily for 3 months. Those who are classified as having Iron Deficiency Anemia will take iron bisglycinate 50mg daily for 3 months. Those classified as having suboptimal Vitamin D or Vitamin D insufficiency will take 1 tab of Vitamin D 5,000 IU supplements daily for 3 months. Those who have Vitamin D deficiency will take 2 tabs of Vitamin D 5,000 IU supplements daily for 3 months.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of Black Collegiate Athletes with Low Energy Availability
Zeitfenster: 9 months

Females with an energy availability score over 45kcal/kg/FFM will be classified as having normal energy availability, those with an energy availability score of 30 to 45 kcal/kg/FFM will be classified as having subclinical low energy availability, and those with an energy availability score of less than 30 kcal/kg/FFM will be classified as having clinical low energy availability.

Males with an energy availability score over 30kcal/kg/FFM will be classified as having normal energy availability, those with an energy availability score of 15 to 30 kcal/kg/FFM will be classified as having subclinical low energy availability, and those with an energy availability score of less than 15 kcal/kg/FFM will be classified as having clinical low energy availability.
9 months
Proportion of Black Collegiate Athletes with Low Vitamin D at Baseline and Following Supplement Intervention Protocol
Zeitfenster: 9 months
Athletes will have Vitamin D levels assessed via blood draws. Those with a Vitamin D level less than 20 ng/mL will be categorized as having Vitamin D deficiency. Those with a Vitamin D level between 20 and 30 ng/mL will be categorized as having Vitamin D insufficiency. Those with a Vitamin D between 30 and 50 ng/mL will be categorized as having suboptimal Vitamin D. Those with a Vitamin D level above 50 ng/mL will be categorized as having optimal Vitamin D.
9 months
Proportions of Black Collegiate Athletes with Iron Deficiency and Iron Deficiency Anemia at Baseline and Following Supplement Intervention Protocol
Zeitfenster: 9 months
Athletes will be identified as having iron deficiency (ID) or iron deficiency anemia (IDA) based on lab results. Any male or female athlete with a ferritin level below 35 ng/mL will be classified as having ID. Any female athlete with a ferritin level below 12 ng/mL and a hemoglobin below 12.0 g/dL will be classified as having IDA. Any male athlete with a ferritin below 35 ng/mL and a hemoglobin below 13.0 g/dL will be classified as having IDA.
9 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of Black Collegiate Athletes with Low Bone Density at Baseline and Following Supplement Intervention Protocol
Zeitfenster: 9 months
Athletes will also complete a Dual-energy X-ray Absorptiometry (DXA) scan. Information from this scan, including the athletes' fat Mass, muscle mass, full body Z-score, and lumbar spine Z-score (as a measure of bone density) will be recorded. A Z-score is a measure of bone mineral density (BMD) that compares an individuals BMD to a reference population of other people that are their same age, sex, and ethnicity. It is expressed as a number of standard deviations from the mean. A Z-score of 0 means the BMD is exactly average for peers. Positive values (a score above 0) indicate higher-than-average BMD. Negative values (a score below 0) indicate lower-than-average BMD. Any athlete with a Z-score less than -1.0 will be classified as having low BMD.
9 months
Proportion of Black Collegiate Athletes with Food Insecurity
Zeitfenster: 9 months
The U.S. Household Food Security Survey Module: Six-item short 101 form, from the United States Department of Agriculture (USDA) will be used. Athletes with a score of 0-1 will be classified as food secure; those with scores from 2-6 will be classified as food insecure.
9 months
Proportion of Black Collegiate Athletes Reporting Dietary Restrictions, Skipping Meals, and Low Dietary Intake of Iron and Vitamin D
Zeitfenster: 9 months
Participants will complete the Athlete Nutrition Screening Survey (ANSS) to evaluate dietary behaviors, exercise energy expenditure, energy and macronutrient intake, food group intake, and dietary supplement use over the previous four weeks. They will also meet one-on-one with a registered dietitian to complete a 24-hour dietary recall.
9 months
Quantity of Sleep among Black Collegiate Athletes
Zeitfenster: 9 months
Participants will wear the Oura ring while sleeping, and it will track how many hours and minutes they are in bed. It will also track how many hours and minutes they are asleep.
9 months
Quality of Sleep Among Black Collegiate Athletes
Zeitfenster: 9 months
Athletes will wear the Oura ring as they sleep. It will determine the quality of their sleep by automatically calculating a sleep score which will range from 0 to 100. The higher the score the better. A score of 85 or higher is optimal, 70 to 84 is good, and <70 needs improvement. Oura Ring does not disclose the exact calculation for the sleep score. However they do state that the sleep score will be based off of 7 different factors: 1) Total Sleep: Did the athlete get enough sleep, 2) Efficiency: How much of the athlete's time in bed did they actually spend sleeping, 3) Restfulness: Did the athlete toss and turn during sleep, 4) Rapid Eye Movement (REM) Sleep: Did the athlete get enough REM sleep, 5) Deep Sleep: Did the athlete get enough deep sleep, 6) Latency: How quickly did the athlete fall asleep, and 7) Timing: When is the athlete getting to sleep and are they going to bed according to their body's natural circadian rhythm.
9 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Morehouse School of Medicine

Mitarbeiter

National Institute on Minority Health and Health Disparities (NIMHD)

Ermittler

  • Hauptermittler: Altelisha Taylor, MD, MPH, Morehouse School of Medicine

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. August 2024

Primärer Abschluss (Tatsächlich)

9. Mai 2025

Studienabschluss (Tatsächlich)

1. Mai 2026

Studienanmeldedaten

Zuerst eingereicht

18. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juni 2026

Zuerst gepostet (Tatsächlich)

8. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2177489
  • 5R25MD007589-17 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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