- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00456690
Endocrine and Nutritional Assessment in B Thalassemia Major
Endocrine and Nutritional Assessment in B Thalassemia Major - A Clinical Trial
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Afula, Israel, 18101
- Pediatric Hematology Unit - HaEmek Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients above age 5 ys treated in the clinic.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Thalassemia Mayor Patients
|
Nutritional status assessment including complete endocrine and lipid laboratory profile and after one year of nutritional follow up a secondary assessment will be done
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BMI
Time Frame: 1 year study
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1 year study
|
Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5190906/2.EMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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