Collegiate Athlete Study

NCT07631312 | Completed

• 2 other identifiers: 21774895R25MD007589-17
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  9 months

Secondary Outcomes (5)

• Proportion of Black Collegiate Athletes with Low Bone Density at Baseline and Following Supplement Intervention Protocol

  9 months

• Proportion of Black Collegiate Athletes with Food Insecurity

  9 months

• Proportion of Black Collegiate Athletes Reporting Dietary Restrictions, Skipping Meals, and Low Dietary Intake of Iron and Vitamin D

  9 months

• Quantity of Sleep among Black Collegiate Athletes

  9 months

• Quality of Sleep Among Black Collegiate Athletes

  9 months

Study Arms (1)

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.

Dietary Supplement: Iron and Vitamin D Deficiencies Correction

Interventions

Iron and Vitamin D Deficiencies Correction DIETARY_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.

Determining Nutritional Status and Treating As Needed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Morehouse School of Medicine: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Related Publications (7)

• 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.

  PMID: 24569429 BACKGROUND

• Nattiv 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.

  PMID: 34091537 BACKGROUND

• Melin 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.

  PMID: 30632422 BACKGROUND

• Heikura 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.

  PMID: 29252050 BACKGROUND

• Barrack 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.

  PMID: 34788580 BACKGROUND

• Edama 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.

  PMID: 33868810 BACKGROUND

• Melanson 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.

  PMID: 28978547 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency; Vitamin D Deficiency

Interventions

Iron

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Altelisha Taylor, MD, MPH

  Morehouse School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 8, 2026
• Study Start: August 19, 2024
• Primary Completion: May 9, 2025
• Study Completion: May 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (1)