- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03161899
Evaluation of Nutritional Status in Thalassemia Major Patients in Assiut Children Hospital
Evaluation of Nutritional Status in Patients With Thalassemia Major in Assiut University Children Hospital
Thalassemia is a blood disorder passed down through families in which the body makes an abnormal form of hemoglobin. There are 2 main types of thalassemia; Alpha & Beta thalassemia. Alpha thalassemia: occurs when a gene or genes related to the alpha globin protein are missing or mutated.
Beta-thalassemia syndromes are a group of hereditary blood disorders characterized by reduced or absent beta globin chain synthesis. Beta-thalassemias can be classified into:
Silent carrier: completely asymptomatic with normal hematological parameters. Beta-thalassaemia minor (beta-thalassaemia trait): usually asymptomatic; diagnosis is made during a work-up for mild anemia.
Beta-thalassaemia intermedia: usually a similar presentation to beta-thalassaemia major; symptoms are usually less pronounced and the course is usually more insidious.
Beta-thalassaemia major : In which there is complete absence of hemoglobin A
Study Overview
Status
Conditions
Detailed Description
In Egypt beta thalassemia-major is the most common type with carrier rate of 5.3 to ≥9%and 1000 new cases born with beta-thalassemia major per 1.5 million live births per year.
Children born with thalassemia major are normal at birth, but develop severe hemolytic anemia during the first year of life. Symptoms are those of anemia (lethargy, poor feeding, pallor…etc.) failure to thrive and organomegaly. Later on they develop signs of extra medullary hematopoiesis .
Optimal nutritional status is important for growth, immune function, bone health and pubertal development . Various reports suggest the incidence of poor growth ranges from 25% to 75% depending on thalassemia syndrome and severity of disease. This marked growth deficits raise a red flag for any pediatrician to evaluate nutritional status of thalassemic patients and detect possible nutritional deficiencies and associated factors.
Etiology of delayed growth and malnutrition reported in thalassemic patient is multifactorial including :
- Nutritional deprivation with or without feeding difficulties arising from fatigue and breathlessness
- Increased energy expenditure secondary to hyper metabolism with or without heart failure
- Gastrointestinal hypoxia which consequently produces anorexia and malabsorption
- Reduction of biosynthetic activity of liver.
- Disturbance of the endocrine function
- Impaired synthetic hepatic function secondary to hemosiderosis and hepatitis.
The main aim of this study is to assess the nutritional status of thalassemic patient attending Assiut university Children hospital and to determine the factors involved.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Assiut, Egypt
- Asmaa Refaat Abdelmonem
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients diagnosed to have thalassemia
Exclusion Criteria:
- patient with any underlaying systemic diseases other than B thalassemia major.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of malnutrition
Time Frame: 12 month
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prevalence of malnutrition among thalassemic children attending assiut university children hospital
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12 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
aetiology poor growth
Time Frame: 12 month
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determination of the most common causes responsible for poor growth seen in thalassemic patients
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12 month
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decrease morbidity
Time Frame: 18 month
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decrease morbidity by providing possible strategies for early prevention of the problem of poor growth occurring in patients with thalassemia major
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18 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: asmaa refaat, MBBCH, Assuit , faculty of medicine, egypt
Publications and helpful links
General Publications
- Soliman AT, El-Matary W, Fattah MM, Nasr IS, El Alaily RK, Thabet MA. The effect of high-calorie diet on nutritional parameters of children with beta-thalassaemia major. Clin Nutr. 2004 Oct;23(5):1153-8. doi: 10.1016/j.clnu.2004.03.001.
- Fung EB. Nutritional deficiencies in patients with thalassemia. Ann N Y Acad Sci. 2010 Aug;1202:188-96. doi: 10.1111/j.1749-6632.2010.05578.x.
- Galanello R, Origa R. Beta-thalassemia. Orphanet J Rare Dis. 2010 May 21;5:11. doi: 10.1186/1750-1172-5-11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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