Relative Energy Deficiency in SportNCT06480682
Relative Energy Deficiency in Sport and Dance
An observational study of Relative Energy Deficiency in Sport and Bone Stress Reaction, run by University of Wolverhampton at 1 site in United Kingdom.
Trial summary
The International Olympic Committee recently published its consensus statement on relative energy deficiency syndrome (REDs) in sport which was followed by a similar version for dance by clinicians and researchers in dance. REDs is a complex multisystem syndrome with low energy availability as its foundation. Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Relative Energy Deficiency in Sport, Bone Stress Reaction
- What is being tested?
- Dual x-ray scan, Blood screen and Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2024to 30 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Dancers: ballet, contemporary dance and musical theatre Combat sports: judo, karate, taekwondo Gymnastics: artistic
Who may be able to join
- Full-time training at either a NGB centre, dance company, vocational dance school or academy
- Engaged in full-time training at start of project
Who cannot join
- Not engaged in full-time training
- Injury preventing engagement in training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Wolverhampton
Walsall, West Midlands, WS1 3BD
Matthew Wyon, PhD, 01902323144, m.wyon@wlv.ac.uk
Ross Cloak, PhD, 0190231285, r.cloak@wlv.ac.uk
About this study
Official title: Prevalence of Relative Energy Deficiency in Sport and Dance
The International Olympic Committee recently published its consensus statement on relative energy deficiency syndrome (REDs) in sport which was followed by a similar version for dance by clinicians and researchers in dance. REDs is a complex multisystem syndrome with low energy availability as its foundation. Dancers and gymnasts, particularly in ballet, have long been reported to have body weight issues with an increase prevalence of eating disorders which has been associated with early onset osteoporosis. Combat sports have a similar issue, with athletes needing to "make weight" to compete in their ideal weight category that has lead to similar eating disorder and associated issues to dance. Currently there are no data on REDs prevalence in dance, gymnastics or combat sports and therefore understanding the underlying prevalence of REDs in both these populations will provide important information for both clinicians and coaches to help develop a safe and healthy environment for their dancers and athletes to compete/perform and to be able to retire from sport/dance without an increased risk of osteoporosis. In a few sports and dance genres, some participants might be more prone to a negative health effect referred to as relative energy deficiency syndrome (REDs). This is an energy deficiency relative to the balance between dietary energy intake and energy availability required to support homeostasis, health and activities of daily living, growth and sporting activities that can result in multiple systems being affected including decreases in bone health, energy metabolism, reproductive function, musculoskeletal health, immunity, glycogen synthesis and cardiovascular and haematological health. The purpose of this study is to examine the prevalence of REDs in specific sports (combat sports and gymnastics) and dance genres (ballet and musical theatre). Voluntary participants will be tested three times a year over a 5-year period. This will include an annual dual-energy x-ray absorptiometry and blood tests plus resting energy expenditure and questionnaires three times a year.
Read the detailed description
Participants will be asked to be available three times for testing over a 12-month period, for a period of 3-years. Their initial test visit will be at a university exercise science laboratory whilst the other testing sessions will occur at their place of work/training.
Each year the initial testing session will include a bone health scan (DXA), a blood sample (2x 5ml samples), a body composition analysis (bioimpedance), resting metabolic rate test and a series of questionnaires. Subsequent test session will include the same tests except the DXA scan unless there is a medical reason to carry out a further scan (two or more bone stress injuries).
The DXA scan, where participants will need to lie still for approximately 20 minutes will monitor body composition, bone mineral density and bone mineral content for the whole body and at the forearm (radius), lower spine (Lumbar 4 and 5) and upper leg (femur). The scan will also look at the ratio between outer (cortical) and inner (trabecular) bone content.
The blood samples will measure a series of markers that have been associated with low energy availability for male and female participants and amenorrhea for female participants.
Anthropometric measurements will consist of body composition analysis will consist of a body composition, stature and body mass. The participant will have their height measured and then stand on bioimpedance scales and hold onto two handles. This will allow changes in body composition changes to be monitored throughout the year without exposing the participant to further radiation from the DXA.
To monitor resting metabolic rate participants will lie down on a bed in a quiet room. They will be fitted with a mask over the mouth and nose that is connected to a breathe-by-breathe gas analyser. They will lie as still as possible for 20-minutes for the test to conclude.
The validated questionnaires (Low Energy Availability Male Questionnaire, Low Energy Availability Female Questionnaire, Health questionnaire) will focus on sleep quality, general health, attitudes towards food and eating, perceptions of energy availability, and mood.
Basic injury incidence data will be provided by the participant's medical team through out the monitoring period. Injury data will consist of location, type and severity of each injury.
Participants' injury incidence and aetiology will be monitored by their club's/company's medical teams and summarised data provided to the research team via a signed medical release agreement. REDs prevalence will be analysed by the research team in conjunction with the participants' medical teams and for those diagnosed with the syndrome the relevant management plan will be put into place for their safe return to activity.
- Being tested
- Dual x-ray scan, Blood screen, Questionnaires, Anthropometric measurements, Resting Metabolic rate
- Keywords
- Judo, Ballet, Gymnastics, Male, Female, Dance, weight category sport
- Medical subject headings
- Relative Energy Deficiency in Sport, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual x-ray scanRadiation
Annual whole body scan monitoring bone mineral density for whole body, radius, L1-4 and femur and body composition
Blood screenDiagnostic test
Three times a year blood samples will be taken to measure: full blood count, ferritin, B12, folate, erythrocyte sedimentation rate (ESR), renal function, liver function, thyroid stimulating hormone (TSH), Free thyroxine (T4), luteinizing hormone (LH), oestradiol, testosterone, follicle-stimulating hormone (FSH), coeliac screen, vitamin D (25(OH)D), Leptin and Ghrelin
QuestionnairesOther
Also called Low Energy Availability Male Questionnaire, Low Energy Availability Female Questionnaire; Consent; Health
Informed consent; Low energy availability questionnaires for males and females; General health including menstrual status (females)
Anthropometric measurementsOther
Three times a year participant's measurements will be taken: stature, body mass and body composition (bio-impedence)
Resting Metabolic rateProcedure or surgery
Resting metabolic rate will be measured by resting gas analysis. Each participant will lie down for a period of 15 minutes, in the final 5 minutes their expired gases are analysed using a breath-by-breath gas analyser (Cortex).
Energy expenditureOther
Energy expenditure was estimated using accelerometery (Genieactive) and activity logs in the participants' normal environment, assessed during 3 weekdays of scheduled dance training and 2 weekend days without scheduled dance training. Focus is on daily energy expenditure
| Study group | Role | What they receive |
|---|---|---|
| Dance | Age: 16-45yrs old Sex: Female and male Activity: Dance (ballet, contemporary, musical theatre); Level: Full-time training at either a dance company, vocational dance school Status: Engaged in full-time training at start of project without activity limiting injury Receives: Radiation: Dual x-ray scan; Diagnostic Test: Blood screen; Other: Questionnaires; Other: Anthropometric measurements; Procedure: Resting Metabolic rate | |
| Combat Sports | Age: 16-45yrs old Sex: Female and male Activity: Combat sports (judo, karaté, taekwondo); Level: Full-time training at either a NGB centre Status: Engaged in full-time training at start of project without activity limiting injury Receives: Radiation: Dual x-ray scan; Diagnostic Test: Blood screen; Other: Questionnaires; Other: Anthropometric measurements; Procedure: Resting Metabolic rate; Other: Energy expenditure | |
| Gymnastics | Age: 16-45yrs old Sex: Female and male Activity: Gymnastics (artistic) Level: Full-time training at either a NGB centre or academy Status: Engaged in full-time training at start of project without activity limiting injury Receives: Radiation: Dual x-ray scan; Diagnostic Test: Blood screen; Other: Questionnaires; Other: Anthropometric measurements; Procedure: Resting Metabolic rate; Other: Energy expenditure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative energy deficiency (REDs)
Prevalence of REDs in cohorts by diagnosis by elimination by medical team.
Measured: Throughout study; an average of 3 times a year
Secondary outcomes (4)
Bone stress injuries
Reported bone stress injuries by the inhouse medical teams
Measured: Number of participants with bone stress injuries. Throughout study an average of 3 times a year
Primary Amenorrhea (females)
Loss of menses for at least 6 months
Measured: Number of participants with primary and secondary amenorrhea. Throughout study an average of 3 times a year
Resting Metabolic rate
Actual resting metabolic rate/estimated metabolic rate below 0.9
Measured: Throughout study; an average of 3 times a year
Monitoring of all blood markers for below normal values (red flags)
Blood markers: full blood count, ferritin, B12, folate, erythrocyte sedimentation rate (ESR), renal function, liver function, thyroid stimulating hormone (TSH), Free thyroxine (T4), luteinizing hormone (LH), oestradiol, testosterone, follicle-stimulating hormone (FSH), coeliac screen, vitamin D (25(OH)D), Leptin and Ghrelin
Measured: Throughout study; an average of 3 times a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start10 Sep 2024 (estimated)
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Relative Energy Deficiency in SportStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wolverhampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Wyon, University of Wolverhampton
- Investigators
- Roger Wolman, PhD, Study chair, Honorary Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480682
- Sponsor's protocol ID
- REDsWyon24
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymised data will be shared via figshare
Publications
Koltun KJ, Strock NCA, Southmayd EA, Oneglia AP, Williams NI, De Souza MJ. Comparison of Female Athlete Triad Coalition and RED-S risk assessment tools. J Sports Sci. 2019 Nov;37(21):2433-2442. doi: 10.1080/02640414.2019.1640551. Epub 2019 Jul 11.
PubMed 31296115Sim A, Burns SF. Review: questionnaires as measures for low energy availability (LEA) and relative energy deficiency in sport (RED-S) in athletes. J Eat Disord. 2021 Mar 31;9(1):41. doi: 10.1186/s40337-021-00396-7.
PubMed 33789771Allen N, Kelly S, Lanfear M, Reynolds A, Clarke R, Mountjoy ML, Wyon M, Wolman R. Relative energy deficiency in dance (RED-D): a consensus method approach to REDs in dance. BMJ Open Sport Exerc Med. 2024 Mar 7;10(1):e001858. doi: 10.1136/bmjsem-2023-001858. eCollection 2024.
PubMed 38463191Mountjoy M, Ackerman KE, Bailey DM, Burke LM, Constantini N, Hackney AC, Heikura IA, Melin A, Pensgaard AM, Stellingwerff T, Sundgot-Borgen JK, Torstveit MK, Jacobsen AU, Verhagen E, Budgett R, Engebretsen L, Erdener U. 2023 International Olympic Committee's (IOC) consensus statement on Relative Energy Deficiency in Sport (REDs). Br J Sports Med. 2023 Sep;57(17):1073-1097. doi: 10.1136/bjsports-2023-106994.
PubMed 37752011Civil R, Lamb A, Loosmore D, Ross L, Livingstone K, Strachan F, Dick JR, Stevenson EJ, Brown MA, Witard OC. Assessment of Dietary Intake, Energy Status, and Factors Associated With RED-S in Vocational Female Ballet Students. Front Nutr. 2019 Jan 9;5:136. doi: 10.3389/fnut.2018.00136. eCollection 2018.
PubMed 30687712Staal S, Sjodin A, Fahrenholtz I, Bonnesen K, Melin AK. Low RMRratio as a Surrogate Marker for Energy Deficiency, the Choice of Predictive Equation Vital for Correctly Identifying Male and Female Ballet Dancers at Risk. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):412-418. doi: 10.1123/ijsnem.2017-0327. Epub 2018 Jun 22.
PubMed 29405782
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Relative Energy Deficiency in Sport and Dance
- ClinicalTrials.gov ID
- NCT06480682
- Acronym / sponsor ID
- REDsWyon24
- Keywords
- Judo, Ballet, Gymnastics, Male, Female, Dance, weight category sport
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of WolverhamptonUniversity, hospital or other
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 28 Jun 2024 (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 International Olympic Committee recently published its consensus statement on relative energy deficiency syndrome (REDs) in sport which was followed by a similar version for dance by clinicians and researchers in dance. REDs is a complex multisystem syndrome with low energy availability as its foundation. Dancers and gymnasts, particularly in ballet, have long been reported to have body weight issues with an increase prevalence of eating disorders which has been associated with early onset osteoporosis. Combat sports have a similar issue, with athletes needing to "make weight" to compete in their ideal weight category that has lead to similar eating disorder and associated issues to dance. Currently there are no data on REDs prevalence in dance, gymnastics or combat sports and therefore understanding the underlying prevalence of REDs in both these populations will provide important information for both clinicians and coaches to help develop a safe and healthy environment for their dancers and athletes to compete/perform and to be able to retire from sport/dance without an increased risk of osteoporosis. In a few sports and dance genres, some participants might be more prone to a negative health effect referred to as relative energy deficiency syndrome (REDs). This is an energy deficiency relative to the balance between dietary energy intake and energy availability required to support homeostasis, health and activities of daily living, growth and sporting activities that can result in multiple systems being affected including decreases in bone health, energy metabolism, reproductive function, musculoskeletal health, immunity, glycogen synthesis and cardiovascular and haematological health. The purpose of this study is to examine the prevalence of REDs in specific sports (combat sports and gymnastics) and dance genres (ballet and musical theatre). Voluntary participants will be tested three times a year over a 5-year period. This will include an annual dual-energy x-ray absorptiometry and blood tests plus resting energy expenditure and questionnaires three times a year.
Detailed description
Participants will be asked to be available three times for testing over a 12-month period, for a period of 3-years. Their initial test visit will be at a university exercise science laboratory whilst the other testing sessions will occur at their place of work/training.
Each year the initial testing session will include a bone health scan (DXA), a blood sample (2x 5ml samples), a body composition analysis (bioimpedance), resting metabolic rate test and a series of questionnaires. Subsequent test session will include the same tests except the DXA scan unless there is a medical reason to carry out a further scan (two or more bone stress injuries).
The DXA scan, where participants will need to lie still for approximately 20 minutes will monitor body composition, bone mineral density and bone mineral content for the whole body and at the forearm (radius), lower spine (Lumbar 4 and 5) and upper leg (femur). The scan will also look at the ratio between outer (cortical) and inner (trabecular) bone content.
The blood samples will measure a series of markers that have been associated with low energy availability for male and female participants and amenorrhea for female participants.
Anthropometric measurements will consist of body composition analysis will consist of a body composition, stature and body mass. The participant will have their height measured and then stand on bioimpedance scales and hold onto two handles. This will allow changes in body composition changes to be monitored throughout the year without exposing the participant to further radiation from the DXA.
To monitor resting metabolic rate participants will lie down on a bed in a quiet room. They will be fitted with a mask over the mouth and nose that is connected to a breathe-by-breathe gas analyser. They will lie as still as possible for 20-minutes for the test to conclude.
The validated questionnaires (Low Energy Availability Male Questionnaire, Low Energy Availability Female Questionnaire, Health questionnaire) will focus on sleep quality, general health, attitudes towards food and eating, perceptions of energy availability, and mood.
Basic injury incidence data will be provided by the participant's medical team through out the monitoring period. Injury data will consist of location, type and severity of each injury.
Participants' injury incidence and aetiology will be monitored by their club's/company's medical teams and summarised data provided to the research team via a signed medical release agreement. REDs prevalence will be analysed by the research team in conjunction with the participants' medical teams and for those diagnosed with the syndrome the relevant management plan will be put into place for their safe return to activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dance | – | Radiation: Dual x-ray scan, Diagnostic Test: Blood screen, Other: Questionnaires, Other: Anthropometric measurements, Procedure: Resting Metabolic rateAge: 16-45yrs old Sex: Female and male Activity: Dance (ballet, contemporary, musical theatre); Level: Full-time training at either a dance company, vocational dance school Status: Engaged in full-time training at start of project without activity limiting injury |
| Combat Sports | – | Radiation: Dual x-ray scan, Diagnostic Test: Blood screen, Other: Questionnaires, Other: Anthropometric measurements, Procedure: Resting Metabolic rate, Other: Energy expenditureAge: 16-45yrs old Sex: Female and male Activity: Combat sports (judo, karaté, taekwondo); Level: Full-time training at either a NGB centre Status: Engaged in full-time training at start of project without activity limiting injury |
| Gymnastics | – | Radiation: Dual x-ray scan, Diagnostic Test: Blood screen, Other: Questionnaires, Other: Anthropometric measurements, Procedure: Resting Metabolic rate, Other: Energy expenditureAge: 16-45yrs old Sex: Female and male Activity: Gymnastics (artistic) Level: Full-time training at either a NGB centre or academy Status: Engaged in full-time training at start of project without activity limiting injury |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Dancers: ballet, contemporary dance and musical theatre Combat sports: judo, karate, taekwondo Gymnastics: artistic
Key inclusion criteria (2 listed)
- Full-time training at either a NGB centre, dance company, vocational dance school or academy
- Engaged in full-time training at start of project
Key exclusion criteria (2 listed)
- Not engaged in full-time training
- Injury preventing engagement in training
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 |
|---|---|---|
| Dual x-ray scanAnnual whole body scan monitoring bone mineral density for whole body, radius, L1-4 and femur and body composition | Radiation | Combat Sports, Dance, Gymnastics |
| Blood screenThree times a year blood samples will be taken to measure: full blood count, ferritin, B12, folate, erythrocyte sedimentation rate (ESR), renal function, liver function, thyroid stimulating hormone (TSH), Free thyroxine (T4), luteinizing hormone (LH), oestradiol, testosterone, follicle-stimulating hormone (FSH), coeliac screen, vitamin D (25(OH)D), Leptin and Ghrelin | Diagnostic test | Combat Sports, Dance, Gymnastics |
| QuestionnairesAlso: Low Energy Availability Male Questionnaire, Low Energy Availability Female Questionnaire; Consent; HealthInformed consent; Low energy availability questionnaires for males and females; General health including menstrual status (females) | Other | Combat Sports, Dance, Gymnastics |
| Anthropometric measurementsThree times a year participant's measurements will be taken: stature, body mass and body composition (bio-impedence) | Other | Combat Sports, Dance, Gymnastics |
| Resting Metabolic rateResting metabolic rate will be measured by resting gas analysis. Each participant will lie down for a period of 15 minutes, in the final 5 minutes their expired gases are analysed using a breath-by-breath gas analyser (Cortex). | Procedure or surgery | Combat Sports, Dance, Gymnastics |
| Energy expenditureEnergy expenditure was estimated using accelerometery (Genieactive) and activity logs in the participants' normal environment, assessed during 3 weekdays of scheduled dance training and 2 weekend days without scheduled dance training. Focus is on daily energy expenditure | Other | Combat Sports, Gymnastics |
Primary outcome
Relative energy deficiency (REDs)
Time frame: Throughout study; an average of 3 times a year
Prevalence of REDs in cohorts by diagnosis by elimination by medical team.
4 secondary outcomes
Bone stress injuries
Time frame: Number of participants with bone stress injuries. Throughout study an average of 3 times a year
Primary Amenorrhea (females)
Time frame: Number of participants with primary and secondary amenorrhea. Throughout study an average of 3 times a year
Resting Metabolic rate
Time frame: Throughout study; an average of 3 times a year
Monitoring of all blood markers for below normal values (red flags)
Time frame: Throughout study; an average of 3 times a year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 31296115Koltun KJ, Strock NCA, Southmayd EA, Oneglia AP, Williams NI, De Souza MJ. Comparison of Female Athlete Triad Coalition and RED-S risk assessment tools. J Sports Sci. 2019 Nov;37(21):2433-2442. doi: 10.1080/02640414.2019.1640551. Epub 2019 Jul 11.
- Background: PubMed 33789771Sim A, Burns SF. Review: questionnaires as measures for low energy availability (LEA) and relative energy deficiency in sport (RED-S) in athletes. J Eat Disord. 2021 Mar 31;9(1):41. doi: 10.1186/s40337-021-00396-7.
- Results publication: PubMed 38463191Allen N, Kelly S, Lanfear M, Reynolds A, Clarke R, Mountjoy ML, Wyon M, Wolman R. Relative energy deficiency in dance (RED-D): a consensus method approach to REDs in dance. BMJ Open Sport Exerc Med. 2024 Mar 7;10(1):e001858. doi: 10.1136/bmjsem-2023-001858. eCollection 2024.
- Results publication: PubMed 37752011Mountjoy M, Ackerman KE, Bailey DM, Burke LM, Constantini N, Hackney AC, Heikura IA, Melin A, Pensgaard AM, Stellingwerff T, Sundgot-Borgen JK, Torstveit MK, Jacobsen AU, Verhagen E, Budgett R, Engebretsen L, Erdener U. 2023 International Olympic Committee's (IOC) consensus statement on Relative Energy Deficiency in Sport (REDs). Br J Sports Med. 2023 Sep;57(17):1073-1097. doi: 10.1136/bjsports-2023-106994.
- Results publication: PubMed 30687712Civil R, Lamb A, Loosmore D, Ross L, Livingstone K, Strachan F, Dick JR, Stevenson EJ, Brown MA, Witard OC. Assessment of Dietary Intake, Energy Status, and Factors Associated With RED-S in Vocational Female Ballet Students. Front Nutr. 2019 Jan 9;5:136. doi: 10.3389/fnut.2018.00136. eCollection 2018.
- Results publication: PubMed 29405782Staal S, Sjodin A, Fahrenholtz I, Bonnesen K, Melin AK. Low RMRratio as a Surrogate Marker for Energy Deficiency, the Choice of Predictive Equation Vital for Correctly Identifying Male and Female Ballet Dancers at Risk. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):412-418. doi: 10.1123/ijsnem.2017-0327. Epub 2018 Jun 22.
- Individual participant dataSharing planned: Yes. All anonymised data will be shared via figshare
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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.
Roger Wolman, PhD study chair
Honorary Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relative Energy Deficiency in Sport and Bone Stress Reaction, run by University of Wolverhampton at 1 site in United Kingdom.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 28 Jun 2024. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew A Wyon, PhD (01902323144, m.wyon@wlv.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative energy deficiency (REDs) (time frame: Throughout study; an average of 3 times a year). 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 NCT06480682, which also lists 6 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 28 Jun 2024.