Body Composition in Thalassemia MajorBC-THALNCT07204015
Body Composition in Pediatric Patients With Thalassemia Major
An observational study of Body Composition in Thalassemia Major, run by Assiut University.
Trial summary
To assess body composition (fat mass, lean mass, and bone mass) in pediatric patients with beta thalassemia major using appropriate tools (e.g.,Bioelectrical impedance analysis (BIA)). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Body Composition in Thalassemia Major
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 2026
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents aged 5 to 18 years with a confirmed diagnosis of beta thalassemia major attending Assiut University Children's Hospital. Both sexes will be included.
Who may be able to join
- Children aged 5-18 years
- Diagnosed with beta thalassemia major
- Receiving regular transfusions
- Informed consent/assent provided.
Who cannot join
- Presence of other chronic systemic diseases
- On medications that significantly affect body composition (e.g., steroids)
- Severe physical or cognitive disability interfering with assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Body Composition in Pediatric Patients With Thalassemia Major Attending Assiut University Children's Hospital
To assess body composition (fat mass, lean mass, and bone mass) in pediatric patients with beta thalassemia major using appropriate tools (e.g.,Bioelectrical impedance analysis (BIA)).
To evaluate the association between body composition and clinical parameters such as transfusion frequency, nutritional status, serum ferritin levels, endocrine complications.
Read the detailed description
Thalassemias are severe inherited anemias characterized by microcytic, hypochromic, and short-lived red blood cells due to defective hemoglobin synthesis(1) β-thalassemias are a heterogeneous group of hereditary hemoglobinopathies characterized by defects in the β-globin chain of hemoglobin and belong to autosomal recessive disorders(2) Three clinical and hematological conditions of increasing severity are recognized and include beta-thalassemia carrier state, thalassemia intermedia, and thalassemia major (3, 4).
Regular blood transfusion is a vital treatment in β-thalassemia major patients to prevent the consequences of anemia. Iron overloading is frequently observed in β-thalassemia major patients with transfusion therapy . Excessive iron can cause multiple organ damage (5, 6, 7, 8).
Patients with β-thalassemia major (BTM) suffer from several patterns of growth retardation including short stature, underweight, wasting, and decreased bone density(9, 10).
Impaired nutritional status has been commonly observed in patients with thalassemia major. Specific nutritional deficiencies, such as vitamin D deficiency, are also often observed due to increased losses of micronutrients or increased endogenous requirements (11).
Patients suffering from thalassemia major have impaired body composition, especially whole-body lean mass and bone mineral density(12, 13). Body composition is influenced by many parameters including age, gender, endocrine system status, nutrition, and exercise (14). All the above parameters are impaired in patients with thalassemia major in addition to hyperactivity of bone marrow, iron overload, and diminished bone mineral density (15, 16).
Patients with thalassemia tend to have increased adiposity(17, 18). These alterations in body composition are more frequently seen in thalassemic patients compared to the general population and are related to the high prevalence of sarcopenic obesity (19).
Bioelectrical impedance analysis (BIA), a technique using electrical properties to analyze body composition. Using BIA provides a more accurate and non-invasive assessment of muscle mass(20).
Body composition in pediatric patients with beta_thalassemia major has not been well studied, especially in Egypt.There is a lack of sufficient data addressing changes in muscle mass, fat distribution, and their metabolic consequences in this group of patients.
This study will provide new insights into body composition profile of thalassemic children in Assisut University Children's Hospital.The results are expected to fill an important gap in knowledge, support early detection of abnormalities, and contribute to better strategies for management and prevention of long_term complications.
- Conditions
- Body Composition in Thalassemia Major
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition parameters (Fat Mass, Fat Free Mass)
Body composition will be assessed using bioelectrical impedance analysis (BIA) to measure fat mass, fat-free mass in pediatric patients with beta thalassemia major.
Measured: Assessed at baseline and every 6 months for up to 12 months.
Secondary outcomes (1)
Association between transfusion frequency, nutritional status, serum ferritin, endocrine complications and body composition.
This outcome evaluates how transfusion burden, nutritional status, iron overload (measured by serum ferritin) and endocrine complications are related to body composition in chronically transfused patients.
Measured: Measured at baseline and every 6 months for up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Body Composition in Thalassemia MajorStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidy Rady Gayed Hennes Saied, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204015
- Sponsor's protocol ID
- Body Composition,Thalassemia
- Acronym
- BC-THAL
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kuriyan R. Body composition techniques. Indian J Med Res. 2018 Nov;148(5):648-658. doi: 10.4103/ijmr.IJMR_1777_18.
PubMed 30666990Visser M, van Venrooij LM, Vulperhorst L, de Vos R, Wisselink W, van Leeuwen PA, de Mol BA. Sarcopenic obesity is associated with adverse clinical outcome after cardiac surgery. Nutr Metab Cardiovasc Dis. 2013 Jun;23(6):511-8. doi: 10.1016/j.numecd.2011.12.001. Epub 2012 Mar 6.
PubMed 22397879Wong P, Fuller PJ, Gillespie MT, Kartsogiannis V, Milat F, Bowden DK, Strauss BJ. The effect of gonadal status on body composition and bone mineral density in transfusion-dependent thalassemia. Osteoporos Int. 2014 Feb;25(2):597-604. doi: 10.1007/s00198-013-2454-y. Epub 2013 Aug 1.
PubMed 23903954Fung EB, Xu Y, Kwiatkowski JL, Vogiatzi MG, Neufeld E, Olivieri N, Vichinsky EP, Giardina PJ; Thalassemia Clinical Research Network. Relationship between chronic transfusion therapy and body composition in subjects with thalassemia. J Pediatr. 2010 Oct;157(4):641-7, 647.e1-2. doi: 10.1016/j.jpeds.2010.04.064. Epub 2010 Jun 12.
PubMed 20547400Katz S, Weinerman S. Osteoporosis and gastrointestinal disease. Gastroenterol Hepatol (N Y). 2010 Aug;6(8):506-17.
PubMed 20978554Casale M, Citarella S, Filosa A, De Michele E, Palmieri F, Ragozzino A, Amendola G, Pugliese U, Tartaglione I, Della Rocca F, Cinque P, Nobili B, Perrotta S. Endocrine function and bone disease during long-term chelation therapy with deferasirox in patients with beta-thalassemia major. Am J Hematol. 2014 Dec;89(12):1102-6. doi: 10.1002/ajh.23844. Epub 2014 Sep 26.
PubMed 25197009De Sanctis V, Soliman AT, Elsedfy H, Skordis N, Kattamis C, Angastiniotis M, Karimi M, Yassin MA, El Awwa A, Stoeva I, Raiola G, Galati MC, Bedair EM, Fiscina B, El Kholy M. Growth and endocrine disorders in thalassemia: The international network on endocrine complications in thalassemia (I-CET) position statement and guidelines. Indian J Endocrinol Metab. 2013 Jan;17(1):8-18. doi: 10.4103/2230-8210.107808.
PubMed 23776848Vlychou M, Alexiou E, Thriskos P, Fezoulidis I, Vassiou K. Body Composition in Adult Patients with Thalassemia Major. Int J Endocrinol. 2016;2016:6218437. doi: 10.1155/2016/6218437. Epub 2016 Nov 10.
PubMed 27956899Lidoriki I, Stavrou G, Schizas D, Frountzas M, Fotis L, Kapelouzou A, Kokkota S, Fyntanidou B, Kotzampassi K. Nutritional Status in a Sample of Patients With beta-Thalassemia Major. Cureus. 2022 Aug 14;14(8):e27985. doi: 10.7759/cureus.27985. eCollection 2022 Aug.
PubMed 36120275Fucharoen S, Ketvichit P, Pootrakul P, Siritanaratkul N, Piankijagum A, Wasi P. Clinical manifestation of beta-thalassemia/hemoglobin E disease. J Pediatr Hematol Oncol. 2000 Nov-Dec;22(6):552-7. doi: 10.1097/00043426-200011000-00022.
PubMed 11132229Fung EB, Xu Y, Trachtenberg F, Odame I, Kwiatkowski JL, Neufeld EJ, Thompson AA, Boudreaux J, Quinn CT, Vichinsky EP; Thalassemia Clinical Research Network. Inadequate dietary intake in patients with thalassemia. J Acad Nutr Diet. 2012 Jul;112(7):980-90. doi: 10.1016/j.jand.2012.01.017. Epub 2012 May 1.
PubMed 22551675Teawtrakul N, Jetsrisuparb A, Pongudom S, Sirijerachai C, Chansung K, Wanitpongpun C, Fucharoen S. Epidemiologic study of major complications in adolescent and adult patients with thalassemia in Northeastern Thailand: the E-SAAN study phase I. Hematology. 2018 Jan;23(1):55-60. doi: 10.1080/10245332.2017.1358845. Epub 2017 Jul 31.
PubMed 28759343Chen YG, Lin CL, Ho CL, Chen YC, Kao CH. Risk of coronary artery disease in transfusion-naive thalassemia populations: A nationwide population-based retrospective cohort study. Eur J Intern Med. 2015 May;26(4):250-4. doi: 10.1016/j.ejim.2015.02.001. Epub 2015 Feb 18.
PubMed 25704855Lobo C, Angulo IL, Aparicio LR, Drelichman GI, Zanichelli MA, Cancado R; RELATH Investigators. Retrospective epidemiological study of Latin American patients with transfusional hemosiderosis: the first Latin American epidemiological study in iron overload--the RELATH study. Hematology. 2011 Sep;16(5):265-73. doi: 10.1179/102453311X13085644680302.
PubMed 21902889Fung EB, Harmatz PR, Lee PD, Milet M, Bellevue R, Jeng MR, Kalinyak KA, Hudes M, Bhatia S, Vichinsky EP; Multi-Centre Study of Iron Overload Research Group. Increased prevalence of iron-overload associated endocrinopathy in thalassaemia versus sickle-cell disease. Br J Haematol. 2006 Nov;135(4):574-82. doi: 10.1111/j.1365-2141.2006.06332.x. Epub 2006 Oct 10.
PubMed 17054676
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition in Pediatric Patients With Thalassemia Major Attending Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT07204015
- Acronym / sponsor ID
- BC-THAL / Body Composition,Thalassemia
- Conditions
- Body Composition in Thalassemia Major
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Oct 2025 (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.
To assess body composition (fat mass, lean mass, and bone mass) in pediatric patients with beta thalassemia major using appropriate tools (e.g.,Bioelectrical impedance analysis (BIA)).
To evaluate the association between body composition and clinical parameters such as transfusion frequency, nutritional status, serum ferritin levels, endocrine complications.
Detailed description
Thalassemias are severe inherited anemias characterized by microcytic, hypochromic, and short-lived red blood cells due to defective hemoglobin synthesis(1) β-thalassemias are a heterogeneous group of hereditary hemoglobinopathies characterized by defects in the β-globin chain of hemoglobin and belong to autosomal recessive disorders(2) Three clinical and hematological conditions of increasing severity are recognized and include beta-thalassemia carrier state, thalassemia intermedia, and thalassemia major (3, 4).
Regular blood transfusion is a vital treatment in β-thalassemia major patients to prevent the consequences of anemia. Iron overloading is frequently observed in β-thalassemia major patients with transfusion therapy . Excessive iron can cause multiple organ damage (5, 6, 7, 8).
Patients with β-thalassemia major (BTM) suffer from several patterns of growth retardation including short stature, underweight, wasting, and decreased bone density(9, 10).
Impaired nutritional status has been commonly observed in patients with thalassemia major. Specific nutritional deficiencies, such as vitamin D deficiency, are also often observed due to increased losses of micronutrients or increased endogenous requirements (11).
Patients suffering from thalassemia major have impaired body composition, especially whole-body lean mass and bone mineral density(12, 13). Body composition is influenced by many parameters including age, gender, endocrine system status, nutrition, and exercise (14). All the above parameters are impaired in patients with thalassemia major in addition to hyperactivity of bone marrow, iron overload, and diminished bone mineral density (15, 16).
Patients with thalassemia tend to have increased adiposity(17, 18). These alterations in body composition are more frequently seen in thalassemic patients compared to the general population and are related to the high prevalence of sarcopenic obesity (19).
Bioelectrical impedance analysis (BIA), a technique using electrical properties to analyze body composition. Using BIA provides a more accurate and non-invasive assessment of muscle mass(20).
Body composition in pediatric patients with beta_thalassemia major has not been well studied, especially in Egypt.There is a lack of sufficient data addressing changes in muscle mass, fat distribution, and their metabolic consequences in this group of patients.
This study will provide new insights into body composition profile of thalassemic children in Assisut University Children's Hospital.The results are expected to fill an important gap in knowledge, support early detection of abnormalities, and contribute to better strategies for management and prevention of long_term complications.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged 5 to 18 years with a confirmed diagnosis of beta thalassemia major attending Assiut University Children's Hospital. Both sexes will be included.
Key inclusion criteria (4 listed)
- Children aged 5-18 years
- Diagnosed with beta thalassemia major
- Receiving regular transfusions
- Informed consent/assent provided.
Key exclusion criteria (3 listed)
- Presence of other chronic systemic diseases
- On medications that significantly affect body composition (e.g., steroids)
- Severe physical or cognitive disability interfering with assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body composition parameters (Fat Mass, Fat Free Mass)
Time frame: Assessed at baseline and every 6 months for up to 12 months.
Body composition will be assessed using bioelectrical impedance analysis (BIA) to measure fat mass, fat-free mass in pediatric patients with beta thalassemia major.
1 secondary outcome
Association between transfusion frequency, nutritional status, serum ferritin, endocrine complications and body composition.
Time frame: Measured at baseline and every 6 months for up to 12 months
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 2 Oct 2025.
- Results publication: PubMed 30666990Kuriyan R. Body composition techniques. Indian J Med Res. 2018 Nov;148(5):648-658. doi: 10.4103/ijmr.IJMR_1777_18.
- Results publication: PubMed 22397879Visser M, van Venrooij LM, Vulperhorst L, de Vos R, Wisselink W, van Leeuwen PA, de Mol BA. Sarcopenic obesity is associated with adverse clinical outcome after cardiac surgery. Nutr Metab Cardiovasc Dis. 2013 Jun;23(6):511-8. doi: 10.1016/j.numecd.2011.12.001. Epub 2012 Mar 6.
- Results publication: PubMed 23903954Wong P, Fuller PJ, Gillespie MT, Kartsogiannis V, Milat F, Bowden DK, Strauss BJ. The effect of gonadal status on body composition and bone mineral density in transfusion-dependent thalassemia. Osteoporos Int. 2014 Feb;25(2):597-604. doi: 10.1007/s00198-013-2454-y. Epub 2013 Aug 1.
- Results publication: PubMed 20547400Fung EB, Xu Y, Kwiatkowski JL, Vogiatzi MG, Neufeld E, Olivieri N, Vichinsky EP, Giardina PJ; Thalassemia Clinical Research Network. Relationship between chronic transfusion therapy and body composition in subjects with thalassemia. J Pediatr. 2010 Oct;157(4):641-7, 647.e1-2. doi: 10.1016/j.jpeds.2010.04.064. Epub 2010 Jun 12.
- Results publication: PubMed 20978554Katz S, Weinerman S. Osteoporosis and gastrointestinal disease. Gastroenterol Hepatol (N Y). 2010 Aug;6(8):506-17.
- Results publication: PubMed 25197009Casale M, Citarella S, Filosa A, De Michele E, Palmieri F, Ragozzino A, Amendola G, Pugliese U, Tartaglione I, Della Rocca F, Cinque P, Nobili B, Perrotta S. Endocrine function and bone disease during long-term chelation therapy with deferasirox in patients with beta-thalassemia major. Am J Hematol. 2014 Dec;89(12):1102-6. doi: 10.1002/ajh.23844. Epub 2014 Sep 26.
- Results publication: PubMed 23776848De Sanctis V, Soliman AT, Elsedfy H, Skordis N, Kattamis C, Angastiniotis M, Karimi M, Yassin MA, El Awwa A, Stoeva I, Raiola G, Galati MC, Bedair EM, Fiscina B, El Kholy M. Growth and endocrine disorders in thalassemia: The international network on endocrine complications in thalassemia (I-CET) position statement and guidelines. Indian J Endocrinol Metab. 2013 Jan;17(1):8-18. doi: 10.4103/2230-8210.107808.
- Results publication: PubMed 27956899Vlychou M, Alexiou E, Thriskos P, Fezoulidis I, Vassiou K. Body Composition in Adult Patients with Thalassemia Major. Int J Endocrinol. 2016;2016:6218437. doi: 10.1155/2016/6218437. Epub 2016 Nov 10.
- Results publication: PubMed 36120275Lidoriki I, Stavrou G, Schizas D, Frountzas M, Fotis L, Kapelouzou A, Kokkota S, Fyntanidou B, Kotzampassi K. Nutritional Status in a Sample of Patients With beta-Thalassemia Major. Cureus. 2022 Aug 14;14(8):e27985. doi: 10.7759/cureus.27985. eCollection 2022 Aug.
- Results publication: PubMed 11132229Fucharoen S, Ketvichit P, Pootrakul P, Siritanaratkul N, Piankijagum A, Wasi P. Clinical manifestation of beta-thalassemia/hemoglobin E disease. J Pediatr Hematol Oncol. 2000 Nov-Dec;22(6):552-7. doi: 10.1097/00043426-200011000-00022.
- Results publication: PubMed 22551675Fung EB, Xu Y, Trachtenberg F, Odame I, Kwiatkowski JL, Neufeld EJ, Thompson AA, Boudreaux J, Quinn CT, Vichinsky EP; Thalassemia Clinical Research Network. Inadequate dietary intake in patients with thalassemia. J Acad Nutr Diet. 2012 Jul;112(7):980-90. doi: 10.1016/j.jand.2012.01.017. Epub 2012 May 1.
- Results publication: PubMed 28759343Teawtrakul N, Jetsrisuparb A, Pongudom S, Sirijerachai C, Chansung K, Wanitpongpun C, Fucharoen S. Epidemiologic study of major complications in adolescent and adult patients with thalassemia in Northeastern Thailand: the E-SAAN study phase I. Hematology. 2018 Jan;23(1):55-60. doi: 10.1080/10245332.2017.1358845. Epub 2017 Jul 31.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition in Thalassemia Major, run by Assiut University.
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 4 inclusion and 3 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Haidy Rady Gayed (01271676606, haidyrady008@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition parameters (Fat Mass, Fat Free Mass) (time frame: Assessed at baseline and every 6 months for up to 12 months.). 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 NCT07204015, which also lists 18 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 2 Oct 2025.