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Endocrine and Nutritional Assessment in B Thalassemia Major

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00456690
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel

Study Description
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Brief Summary:

B Thalassemia patients developed short stature and low weight in spite no evident endocrine abnormalities. One hypothesis is that they developed some degree of malnutrition,then the purpose of this study is to assess the nutritional status before nutritional intervention and after one year. Siblings of the patients will serve as a control group.

BMI, lipid and endocrine profile and leptin levels will be analysed in the study group only.


Condition or disease Intervention/treatment Phase
Thalassemia Other: Nutritional recommendations Not Applicable

Detailed Description:
The nutritionist will advice the patients about calories requirement and intake, balance diet and follow up the patients during the study period of one year. No special medicaments or drug therapy will be provided as part of the study protocol
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Endocrine and Nutritional Assessment in B Thalassemia Major - A Clinical Trial
Study Start Date : May 2007
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Thalassemia Mayor Patients
 Other: Nutritional recommendations
Nutritional status assessment including complete endocrine and lipid laboratory profile and after one year of nutritional follow up a secondary assessment will be done


Outcome Measures
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Primary Outcome Measures :
  1. BMI [ Time Frame: 1 year study ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients above age 5 ys treated in the clinic.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456690


Locations
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Israel
Pediatric Hematology Unit - HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Carina Levin, MD Pediatric Hematology Unit, Ha'Emek Medical Center
Study Director: Ariel Koren, MD Pediatric Hematology Unit - Ha'Emek Medical Center
More Information
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Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00456690    
Other Study ID Numbers: 5190906/2.EMC
First Posted: April 5, 2007    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Keywords provided by Dr Koren Ariel, HaEmek Medical Center, Israel:
Thalassemia
Nutrition
Endocrine
BMI
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn