Evaluation of Nutritional Status in Thalassemia Major Patients in Assiut Children Hospital

• ClinicalTrials.gov Identifier: NCT03161899
• Recruitment Status: Completed
• First Posted: May 22, 2017
• Last Update Posted: July 30, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): ARAbdelmonem, Assiut University

Tracking Information

• First Submitted Date: May 19, 2017
• First Posted Date: May 22, 2017
• Last Update Posted Date: July 30, 2020
• Actual Study Start Date: December 15, 2018
• Actual Primary Completion Date: May 24, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 20, 2017)

percentage of malnutrition [ Time Frame: 12 month ]

prevalence of malnutrition among thalassemic children attending assiut university children hospital

Original Primary Outcome Measures (submitted: May 19, 2017)

percentage of malnutrition [ Time Frame: 12 month ]

prevelance of malnutrition among thalassemic children attending assiut university children hospital

Current Secondary Outcome Measures (submitted: May 20, 2017)

• aetiology poor growth [ Time Frame: 12 month ]
  determination of the most common causes responsible for poor growth seen in thalassemic patients
• decrease morbidity [ Time Frame: 18 month ]
  decrease morbidity by providing possible strategies for early prevention of the problem of poor growth occurring in patients with thalassemia major

Original Secondary Outcome Measures (submitted: May 19, 2017)

• aetiology poor growth [ Time Frame: 12 month ]
  etermination of the most common causes responsible for poor growth seen in thalassemic patients
• decrease morbidity [ Time Frame: 18 month ]
  decrease morbidity by providing possible strategies for early prevention of the problem of poor growth occurring in patients with thalassemia major

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Nutritional Status in Thalassemia Major Patients in Assiut Children Hospital
• Official Title: Evaluation of Nutritional Status in Patients With Thalassemia Major in Assiut University Children Hospital

Brief Summary

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

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 :

1. Nutritional deprivation with or without feeding difficulties arising from fatigue and breathlessness
2. Increased energy expenditure secondary to hyper metabolism with or without heart failure
3. Gastrointestinal hypoxia which consequently produces anorexia and malabsorption
4. Reduction of biosynthetic activity of liver.
5. Disturbance of the endocrine function
6. 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: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: all beta thalassemic patients attending the children Hematology Clinic, Children Hospital, Assiut University, during the period of 1st of June 2017 till 31 th of may 2018.
• Condition: Thalassemia Major
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 30, 2017): 246
• Original Estimated Enrollment (submitted: May 19, 2017): 274
• Actual Study Completion Date: July 20, 2020
• Actual Primary Completion Date: May 24, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• patients diagnosed to have thalassemia

Exclusion Criteria:

• patient with any underlaying systemic diseases other than B thalassemia major.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 14 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03161899
• Other Study ID Numbers: ENST
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: ARAbdelmonem, Assiut University
• Original Responsible Party: arabdelmonem, Assiut University, Assiut ,Egypt
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: asmaa refaat, MBBCH; Assuit , faculty of medicine, egypt

• PRS Account: Assiut University
• Verification Date: July 2020