NCT01183377

Brief Summary

Women's evermore presence in professional and athletic sports has revealed sound evidence on the existence of female athlete triad among the world's elite female athletes. This triad consists of eating disorders, amenorrhea and osteoporosis. It has been stated that all female athletes are potentially at risk, but it is not clear to what extent those exercising at different levels are at risk of this syndrome/triad. Since the manifestation of this triad is often denied, or under-reported, appropriate screening methods are required to identify the symptoms. There is still no clear-cut information available on the incidence of this triad in Iran. And there are religious and cultural differences between Iran's elite female athletes and those in other countries. Therefore, in order to meet Iranian female athletes' needs, the investigators decided to determine the frequency of the female athlete triad in Iran.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
Last Updated

August 17, 2010

Status Verified

August 1, 2010

Enrollment Period

2.3 years

First QC Date

August 13, 2010

Last Update Submit

August 16, 2010

Conditions

Keywords

Female Athlete Triad syndromEating disorderosteoprosis

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Female Athlete Triad among Elite female athlete in Iran in 2006

    24 month

Secondary Outcomes (1)

  • prevalence of menstrual disorder in female athlete in Iran in 2006

    24 month

Study Arms (1)

1

Female athlete Triad syndrom was based on menstrual disorder,Eating Disorder and bone loss

Eligibility Criteria

Age13 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Study population: Professional Iranian female athletes who are members in national teams or federations sports and champion team in Tehran

You may qualify if:

  • All Elite Female athletes who play in international teams in sport federation or champion Team in Tehran between 13-45 years old.

You may not qualify if:

  • The 13-15 year old female athletes who are not manarch with secondary sex charactristics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Research Center, Shariati Hospital

Tehran, Tehran Province, 14114, Iran

Location

MeSH Terms

Conditions

Menstruation DisturbancesFeeding and Eating DisordersBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and SymptomsMental DisordersBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Haleh Dadgostar, MD

    Rheumatology Research Center, Tehran University for Medical Sciences

    STUDY DIRECTOR
  • Fereydoun Davatchi, MD

    Rheumatology Research Center, Tehran University for Medical Sciences

    PRINCIPAL INVESTIGATOR
  • Shafie Movaseghi, MD

    Rheumatology Research Center, Tehran University for Medical Sciences

    PRINCIPAL INVESTIGATOR
  • ashraf Aleyasin, MD

    Tehran University for Medical Sciences

    PRINCIPAL INVESTIGATOR
  • mohamad hosein Forozanfar, MD

    Rheumatology Research Center, Tehran University for Medical Sciences

    PRINCIPAL INVESTIGATOR
  • Talia Alenabi, MD

    Sport Medicine Federation of Islamic Republic Of Iran

    PRINCIPAL INVESTIGATOR
  • Narges Chime, MD

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR
  • pooneh Kimia ghalam, MD

    Health ministry of Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2010

First Posted

August 17, 2010

Study Start

October 1, 2006

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

August 17, 2010

Record last verified: 2010-08

Locations