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Endocrine and Nutritional Assessment in B Thalassemia Major

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00456690
First received: April 4, 2007
Last updated: September 3, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention
Thalassemia
 Other: Nutritional recommendations

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Endocrine and Nutritional Assessment in B Thalassemia Major - A Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Thalassemia
U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • BMI [ Time Frame: 1 year study ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   5 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients above age 5 ys treated in the clinic.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456690

Locations
Israel
Pediatric Hematology Unit - HaEmek Medical Center Recruiting
Afula, Israel, 18101
Contact: Ariel Koren, MD     972-4-6495576 ext 5576     koren_a@clalit.org.il    
Principal Investigator: Carina Levin, MD            
Sub-Investigator: Ariel Koren, MD            
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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

No publications provided

Responsible Party: Dr Koren Ariel, Pediatric Hematology Unit - HaEmek Medical Center - Afula - Israel
ClinicalTrials.gov Identifier: NCT00456690     History of Changes
Other Study ID Numbers: 5190906/2.EMC
Study First Received: April 4, 2007
Last Updated: September 3, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Thalassemia
Nutrition
Endocrine
BMI

Additional relevant MeSH terms:
Beta-Thalassemia
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 23, 2013