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Collegiate Athlete Study

2026년 6월 2일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

36

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Georgia
      • Atlanta, Georgia, 미국, 30310
        • Morehouse School of Medicine

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Determining Nutritional Status and Treating As Needed
Determining energy availability, nutritional status and bone density, then providing iron and vitamin D supplementation as needed.

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of Black Collegiate Athletes with Low Energy Availability
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of Black Collegiate Athletes with Low Bone Density at Baseline and Following Supplement Intervention Protocol
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Altelisha Taylor, MD, MPH, Morehouse School of Medicine

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 8월 19일

기본 완료 (실제)

2025년 5월 9일

연구 완료 (실제)

2026년 5월 1일

연구 등록 날짜

최초 제출

2026년 5월 18일

QC 기준을 충족하는 최초 제출

2026년 6월 2일

처음 게시됨 (실제)

2026년 6월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 2일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2177489
  • 5R25MD007589-17 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .