Iron DeficiencyNCT07631312
Collegiate Athlete Study
A study testing Iron and Vitamin D Deficiencies Correction in people with Iron Deficiency and Iron Deficiency Anemia (IDA), run by Morehouse School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Iron Deficiency Anemia (IDA), Vitamin D Deficiency
- What is being tested?
- Iron and Vitamin D Deficiencies Correction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Members of an HBCU cross-country or track \& field team
- 18 years of age or older
- Self-identification as Black or African American
Who cannot join
- -Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Morehouse School of Medicine
Atlanta, Georgia, 30310
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Iron Deficiency, Iron Deficiency Anemia (IDA), Vitamin D Deficiency, Vitamin D Insufficiency, Low Energy Availability, Bone Density
- Being tested
- Iron and Vitamin D Deficiencies Correction
- Keywords
- Nutrient deficiencies, performance, Sports Nutrition, Bone Health, Energy Availability
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron and Vitamin D Deficiencies CorrectionDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Determining Nutritional Status and Treating As Needed | Experimental | Determining energy availability, nutritional status and bone density, then providing iron and vitamin D supplementation as needed. Receives: Dietary Supplement: Iron and Vitamin D Deficiencies Correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Black Collegiate Athletes with Low Energy Availability
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.
Measured: 9 months
Proportion of Black Collegiate Athletes with Low Vitamin D at Baseline and Following Supplement Intervention Protocol
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.
Measured: 9 months
Proportions of Black Collegiate Athletes with Iron Deficiency and Iron Deficiency Anemia at Baseline and Following Supplement Intervention Protocol
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.
Measured: 9 months
Secondary outcomes (5)
Proportion of Black Collegiate Athletes with Low Bone Density at Baseline and Following Supplement Intervention Protocol
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.
Measured: 9 months
Proportion of Black Collegiate Athletes with Food Insecurity
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.
Measured: 9 months
Proportion of Black Collegiate Athletes Reporting Dietary Restrictions, Skipping Meals, and Low Dietary Intake of Iron and Vitamin D
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.
Measured: 9 months
Quantity of Sleep among Black Collegiate Athletes
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.
Measured: 9 months
Quality of Sleep Among Black Collegiate Athletes
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start19 Aug 2024
- Primary completion9 May 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Collegiate athletes will complete baseline bone density scans, dietary assessments, caloric expenditure testing, and blood draws to evaluate energy availability and to also determine serum ferritin, hemoglobin, and Vitamin D levels. Athletes who are found to have low iron and/or low Vitamin D will be given 3-months of supplementation with 5,000 IU or 10,000 IU vitamin D3 and/or 25 mg or 50 mg ferrous bisglycinate according to baseline vitamin D and iron status. After the 3-month supplementation period, bone density and serum levels of ferritin, hemoglobin, and Vitamin D levels will be re-evaluated.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morehouse School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Altelisha Taylor, MD, MPH, Principal investigator, Morehouse School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631312
- Sponsor's protocol ID
- 2177489
- Other IDs
- 5R25MD007589-17
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Souza MJ, Nattiv A, Joy E, Misra M, Williams NI, Mallinson RJ, Gibbs JC, Olmsted M, Goolsby M, Matheson G; Female Athlete Triad Coalition; American College of Sports Medicine; American Medical Society for Sports Medicine; American Bone Health Alliance. 2014 Female Athlete Triad Coalition consensus statement on treatment and return to play of the female athlete triad: 1st International Conference held in San Francisco, CA, May 2012, and 2nd International Conference held in Indianapolis, IN, May 2013. Clin J Sport Med. 2014 Mar;24(2):96-119. doi: 10.1097/JSM.0000000000000085.
PubMed 24569429Nattiv A, De Souza MJ, Koltun KJ, Misra M, Kussman A, Williams NI, Barrack MT, Kraus E, Joy E, Fredericson M. The Male Athlete Triad-A Consensus Statement From the Female and Male Athlete Triad Coalition Part 1: Definition and Scientific Basis. Clin J Sport Med. 2021 Jul 1;31(4):335-348. doi: 10.1097/JSM.0000000000000946.
PubMed 34091537Melin AK, Heikura IA, Tenforde A, Mountjoy M. Energy Availability in Athletics: Health, Performance, and Physique. Int J Sport Nutr Exerc Metab. 2019 Mar 1;29(2):152-164. doi: 10.1123/ijsnem.2018-0201. Epub 2019 Feb 26.
PubMed 30632422Heikura IA, Uusitalo ALT, Stellingwerff T, Bergland D, Mero AA, Burke LM. Low Energy Availability Is Difficult to Assess but Outcomes Have Large Impact on Bone Injury Rates in Elite Distance Athletes. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):403-411. doi: 10.1123/ijsnem.2017-0313. Epub 2018 Jun 12.
PubMed 29252050Barrack MT, Gray VB, Olson C, Richard C, West J. Comparative analysis between a brief nutrition screening survey and validated food frequency questionnaire among physically active college students. J Am Coll Health. 2023 Dec;71(9):2697-2704. doi: 10.1080/07448481.2021.1987248. Epub 2021 Nov 17.
PubMed 34788580Edama M, Inaba H, Hoshino F, Natsui S, Maruyama S, Omori G. The relationship between the female athlete triad and injury rates in collegiate female athletes. PeerJ. 2021 Apr 6;9:e11092. doi: 10.7717/peerj.11092. eCollection 2021.
PubMed 33868810Melanson EL, Swibas T, Kohrt WM, Catenacci VA, Creasy SA, Plasqui G, Wouters L, Speakman JR, Berman ESF. Validation of the doubly labeled water method using off-axis integrated cavity output spectroscopy and isotope ratio mass spectrometry. Am J Physiol Endocrinol Metab. 2018 Feb 1;314(2):E124-E130. doi: 10.1152/ajpendo.00241.2017. Epub 2017 Oct 3.
PubMed 28978547
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Energy Availability, Iron Deficiency, Low Vitamin D, and Male and Female Athlete Triad Risk Among Black Collegiate Athletes - A Pilot Study
- ClinicalTrials.gov ID
- NCT07631312
- Acronym / sponsor ID
- 2177489
- Conditions
- Iron Deficiency, Iron Deficiency Anemia (IDA), Vitamin D Deficiency, Vitamin D Insufficiency, Low Energy Availability, Bone Density
- Keywords
- Nutrient deficiencies, performance, Sports Nutrition, Bone Health, Energy Availability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Morehouse School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Collegiate athletes will complete baseline bone density scans, dietary assessments, caloric expenditure testing, and blood draws to evaluate energy availability and to also determine serum ferritin, hemoglobin, and Vitamin D levels. Athletes who are found to have low iron and/or low Vitamin D will be given 3-months of supplementation with 5,000 IU or 10,000 IU vitamin D3 and/or 25 mg or 50 mg ferrous bisglycinate according to baseline vitamin D and iron status. After the 3-month supplementation period, bone density and serum levels of ferritin, hemoglobin, and Vitamin D levels will be re-evaluated.
| Arm | Type | Receives |
|---|---|---|
| Determining Nutritional Status and Treating As Needed | Experimental | Dietary Supplement: Iron and Vitamin D Deficiencies CorrectionDetermining energy availability, nutritional status and bone density, then providing iron and vitamin D supplementation as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Members of an HBCU cross-country or track \& field team
- 18 years of age or older
- Self-identification as Black or African American
Key exclusion criteria (1 listed)
- -Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron and Vitamin D Deficiencies CorrectionParticipants 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. | Dietary supplement | Determining Nutritional Status and Treating As Needed |
Primary outcome
Proportion of Black Collegiate Athletes with Low Energy Availability
Time frame: 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.
Proportion of Black Collegiate Athletes with Low Vitamin D at Baseline and Following Supplement Intervention Protocol
Time frame: 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.
Proportions of Black Collegiate Athletes with Iron Deficiency and Iron Deficiency Anemia at Baseline and Following Supplement Intervention Protocol
Time frame: 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.
5 secondary outcomes
Proportion of Black Collegiate Athletes with Low Bone Density at Baseline and Following Supplement Intervention Protocol
Time frame: 9 months
Proportion of Black Collegiate Athletes with Food Insecurity
Time frame: 9 months
Proportion of Black Collegiate Athletes Reporting Dietary Restrictions, Skipping Meals, and Low Dietary Intake of Iron and Vitamin D
Time frame: 9 months
Quantity of Sleep among Black Collegiate Athletes
Time frame: 9 months
Quality of Sleep Among Black Collegiate Athletes
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 24569429De Souza MJ, Nattiv A, Joy E, Misra M, Williams NI, Mallinson RJ, Gibbs JC, Olmsted M, Goolsby M, Matheson G; Female Athlete Triad Coalition; American College of Sports Medicine; American Medical Society for Sports Medicine; American Bone Health Alliance. 2014 Female Athlete Triad Coalition consensus statement on treatment and return to play of the female athlete triad: 1st International Conference held in San Francisco, CA, May 2012, and 2nd International Conference held in Indianapolis, IN, May 2013. Clin J Sport Med. 2014 Mar;24(2):96-119. doi: 10.1097/JSM.0000000000000085.
- Background: PubMed 34091537Nattiv A, De Souza MJ, Koltun KJ, Misra M, Kussman A, Williams NI, Barrack MT, Kraus E, Joy E, Fredericson M. The Male Athlete Triad-A Consensus Statement From the Female and Male Athlete Triad Coalition Part 1: Definition and Scientific Basis. Clin J Sport Med. 2021 Jul 1;31(4):335-348. doi: 10.1097/JSM.0000000000000946.
- Background: PubMed 30632422Melin AK, Heikura IA, Tenforde A, Mountjoy M. Energy Availability in Athletics: Health, Performance, and Physique. Int J Sport Nutr Exerc Metab. 2019 Mar 1;29(2):152-164. doi: 10.1123/ijsnem.2018-0201. Epub 2019 Feb 26.
- Background: PubMed 29252050Heikura IA, Uusitalo ALT, Stellingwerff T, Bergland D, Mero AA, Burke LM. Low Energy Availability Is Difficult to Assess but Outcomes Have Large Impact on Bone Injury Rates in Elite Distance Athletes. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):403-411. doi: 10.1123/ijsnem.2017-0313. Epub 2018 Jun 12.
- Background: PubMed 34788580Barrack MT, Gray VB, Olson C, Richard C, West J. Comparative analysis between a brief nutrition screening survey and validated food frequency questionnaire among physically active college students. J Am Coll Health. 2023 Dec;71(9):2697-2704. doi: 10.1080/07448481.2021.1987248. Epub 2021 Nov 17.
- Background: PubMed 33868810Edama M, Inaba H, Hoshino F, Natsui S, Maruyama S, Omori G. The relationship between the female athlete triad and injury rates in collegiate female athletes. PeerJ. 2021 Apr 6;9:e11092. doi: 10.7717/peerj.11092. eCollection 2021.
- Background: PubMed 28978547Melanson EL, Swibas T, Kohrt WM, Catenacci VA, Creasy SA, Plasqui G, Wouters L, Speakman JR, Berman ESF. Validation of the doubly labeled water method using off-axis integrated cavity output spectroscopy and isotope ratio mass spectrometry. Am J Physiol Endocrinol Metab. 2018 Feb 1;314(2):E124-E130. doi: 10.1152/ajpendo.00241.2017. Epub 2017 Oct 3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Altelisha Taylor, MD, MPH principal investigator
Morehouse School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron and Vitamin D Deficiencies Correction in people with Iron Deficiency and Iron Deficiency Anemia (IDA), run by Morehouse School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Black Collegiate Athletes with Low Energy Availability (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07631312, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.