Endocrine and Nutritional Assessment in B Thalassemia Major

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Completed

CT.gov ID

NCT00456690

Collaborator

(none)

133

Enrollment

Location

Arm

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thalassemia	Other: Nutritional recommendations	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

133 participants

Allocation:

N/A

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

BMI [1 year study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients above age 5 ys treated in the clinic.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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