Endocrine and Nutritional Assessment in B Thalassemia Major

October 30, 2019 updated by: Dr Koren Ariel, HaEmek Medical Center, Israel

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

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • Pediatric Hematology Unit - HaEmek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BMI
Time Frame: 1 year study
1 year study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 5, 2007

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

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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