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NCT00456690 Clinical Trial

Endocrine and Nutritional Assessment in B Thalassemia Major

Thalassemia Clinical Trial

Official title:
Endocrine and Nutritional Assessment in B Thalassemia Major - A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00456690
Other study ID # 5190906/2.EMC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2007
Est. completion date December 2014

Study information
Verified date October 2019
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 133
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 5 Years to 40 Years
Eligibility Inclusion Criteria:

- All patients above age 5 ys treated in the clinic.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Pediatric Hematology Unit - HaEmek Medical Center Afula

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary BMI 1 year study
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