Back to resultsEndocrine and Nutritional Assessment in B Thalassemia Major
Primary Purpose
Thalassemia
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Nutritional recommendations
Sponsored by
About this trial
This is an interventional supportive care trial for Thalassemia focused on measuring Thalassemia, Nutrition, Endocrine, BMI
Eligibility Criteria
Inclusion Criteria:
- All patients above age 5 ys treated in the clinic.
Sites / Locations
- Pediatric Hematology Unit - HaEmek Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Thalassemia Mayor Patients
Outcomes
Primary Outcome Measures
BMI
Secondary Outcome Measures
Full Information
NCT ID
NCT00456690
First Posted
April 4, 2007
Last Updated
October 30, 2019
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00456690
Brief Title
Endocrine and Nutritional Assessment in B Thalassemia Major
Official Title
Endocrine and Nutritional Assessment in B Thalassemia Major - A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia
Keywords
Thalassemia, Nutrition, Endocrine, BMI
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Thalassemia Mayor Patients
Intervention Type
Other
Intervention Name(s)
Nutritional recommendations
Intervention Description
Nutritional status assessment including complete endocrine and lipid laboratory profile and after one year of nutritional follow up a secondary assessment will be done
Primary Outcome Measure Information:
Title
BMI
Time Frame
1 year study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients above age 5 ys treated in the clinic.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carina Levin, MD
Organizational Affiliation
Pediatric Hematology Unit, Ha'Emek Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ariel Koren, MD
Organizational Affiliation
Pediatric Hematology Unit - Ha'Emek Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Pediatric Hematology Unit - HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Endocrine and Nutritional Assessment in B Thalassemia Major
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