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Collegiate Athlete Study

2 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

36

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30310
        • Morehouse School of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Determining Nutritional Status and Treating As Needed
Determining energy availability, nutritional status and bone density, then providing iron and vitamin D supplementation as needed.
Integratore alimentare: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Black Collegiate Athletes with Low Energy Availability
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Black Collegiate Athletes with Low Bone Density at Baseline and Following Supplement Intervention Protocol
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Morehouse School of Medicine

Collaboratori

National Institute on Minority Health and Health Disparities (NIMHD)

Investigatori

  • Investigatore principale: Altelisha Taylor, MD, MPH, Morehouse School of Medicine

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 agosto 2024

Completamento primario (Effettivo)

9 maggio 2025

Completamento dello studio (Effettivo)

1 maggio 2026

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2177489
  • 5R25MD007589-17 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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