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

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ClinicalTrials.gov Identifier: NCT03161899
Recruitment Status : Unknown
Verified July 2017 by ARAbdelmonem, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 22, 2017
Last Update Posted : July 19, 2017
Sponsor:
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 19, 2017
Estimated Study Start Date October 2017
Estimated Primary Completion Date May 31, 2018   (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
Change History Complete list of historical versions of study NCT03161899 on ClinicalTrials.gov Archive Site
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 30, 2017)
246
Original Estimated Enrollment
 (submitted: May 19, 2017)
274
Estimated Study Completion Date December 1, 2018
Estimated Primary Completion Date May 31, 2018   (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 Not Provided
Removed Location Countries  
 
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
Responsible Party ARAbdelmonem, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Principal Investigator: asmaa refaat, MBBCH Assuit , faculty of medicine, egypt
PRS Account Assiut University
Verification Date July 2017