Endocrine and Nutritional Assessment in B Thalassemia Major

HaEmek Medical Center, Israel

Status: Completed

Conditions: Thalassemia

Treatments: Other: Nutritional recommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT00456690

5190906/2.EMC

Details and patient eligibility

About

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.

Full 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

Enrollment: 133 patients

Sex: All

Ages: 5 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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133 participants in 1 patient group

1

Experimental group

Description:

Thalassemia Mayor Patients

Treatment:

Other: Nutritional recommendations