Endocrine and Nutritional Assessment in B Thalassemia Major

NCT ID: NCT00456690

Last Updated: 2019-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Thalassemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Thalassemia Mayor Patients

Group Type EXPERIMENTAL

Nutritional recommendations

Intervention Type OTHER

Nutritional status assessment including complete endocrine and lipid laboratory profile and after one year of nutritional follow up a secondary assessment will be done

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients above age 5 ys treated in the clinic.
Minimum Eligible Age

5 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Dr Koren Ariel

Head of Pediatric Hematology Unit and Pediatric Dpt B

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carina Levin, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Hematology Unit, Ha'Emek Medical Center

Ariel Koren, MD

Role: STUDY_DIRECTOR

Pediatric Hematology Unit - Ha'Emek Medical Center

Locations

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Pediatric Hematology Unit - HaEmek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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5190906/2.EMC

Identifier Type: -

Identifier Source: org_study_id

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