NCT05707455

Brief Summary

This study aimed to evaluate the hematological factors and iron status in aerobic versus anaerobic training in athletic females.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

January 20, 2023

Last Update Submit

September 24, 2023

Conditions

Sports Anemia

Keywords

Hematological factorsiron statusaerobicanaerobicathletic femalesadolescence

Outcome Measures

Primary Outcomes (7)

  • Assessment of hemoglobin (Hb)

    Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure hemoglobin (Hb).

    2 months

  • Assessment of hematocrit (Hct)

    Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure hematocrit (Hct).

    2 months

  • Assessment of red blood cell (RBC) count

    Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure red blood cell (RBC) count.

    2 months

  • Assessment of mean corpuscular volume (MCV)

    Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure mean corpuscular volume (MCV).

    2 months

  • Assessment of mean corpuscular hemoglobin concentration (MCHC)

    Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure mean corpuscular hemoglobin concentration (MCHC).

    2 months

  • Assessment of serum transferrin

    Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. The serum sample was centrifuged, and the serum transferrin was measured using COBAS Integra 400 plus, Switzerland.

    2 months

  • Assessment of serum ferritin

    Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. The serum sample was centrifuged, and the serum ferritin was measured using ADVIA Centaur XPT, Germany.

    2 months

Secondary Outcomes (4)

  • Anthropometric measures

    2 months

  • Assessment of participation age to sport

    2 months

  • Assessment of number of hours of training per week

    2 months

  • Assessment of training experience

    2 months

Study Arms (2)

Aerobic group

long distance runners

Other: evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.

Anaerobic group

broad jumpers

Other: evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.

Interventions

evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.OTHER

evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.

Aerobic groupAnaerobic group

Eligibility Criteria

Age16 Years - 19 Years
Sexfemale(Gender-based eligibility)
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

They were chosen via advertisement in local Cairo clubs.

You may qualify if:

  • Healthy, virginal, nonsmoker, female athletes.
  • Age from 16 to 19 years.
  • Body mass index \< 25 kg/m2.
  • Having the same socio-economic level.
  • Following a normal balanced nutrition.

You may not qualify if:

  • Using any medical or hormonal therapy that might influence the iron status.
  • Vegetarian athletes.
  • Having menorrhagia or amenorrhea.
  • Chronic inflammatory condition or existing infection.
  • Diabetic, hypertensive or cardiac athletes.
  • Haematological disease (with the exception of iron deficiency with or without anaemia).
  • Having transfusion of blood.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local clubs

Cairo, Egypt

Location

MeSH Terms

Interventions

HematocritErythrocyte CountErythrocyte Indices

Intervention Hierarchy (Ancestors)

Hematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesHemorheologyBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaBlood Cell CountCell CountCytological TechniquesCell Physiological Phenomena

Study Officials

  • Doaa A Osman, Assis. Prof.

    Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 20, 2023

First Posted

February 1, 2023

Study Start

September 1, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations

EG(1)