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Trial record 11 of 275 for:    "Thalassemia"

Endocrine and Nutritional Assessment in B Thalassemia Major

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00456690
First Posted: April 5, 2007
Last Update Posted: September 1, 2015
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.
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
  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
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

Resource links provided by NLM:


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

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

Enrollment: 133
Study Start Date: May 2007
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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

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
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
Israel
Pediatric Hematology Unit - HaEmek Medical Center
Afula, Israel, 18101
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

Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00456690     History of Changes
Other Study ID Numbers: 5190906/2.EMC
First Submitted: April 4, 2007
First Posted: April 5, 2007
Last Update Posted: September 1, 2015
Last Verified: August 2015

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

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