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Endocrine and Nutritional Assessment in B Thalassemia Major

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00456690
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel

Tracking Information
First Submitted Date  ICMJE April 4, 2007
First Posted Date  ICMJE April 5, 2007
Last Update Posted Date November 1, 2019
Study Start Date  ICMJE May 2007
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2009)		 BMI [ Time Frame: 1 year study ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2007)
  • Weight
  • Stature
  • BMI
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2007)
  • Endocrine tests
  • Leptine
  • Lipid profile
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endocrine and Nutritional Assessment in B Thalassemia Major
Official Title  ICMJE Endocrine and Nutritional Assessment in B Thalassemia Major - A Clinical Trial
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Thalassemia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
Thalassemia Mayor Patients
Intervention: Other: Nutritional recommendations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2015)		 133
Original Enrollment  ICMJE
 (submitted: April 4, 2007)		 30
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients above age 5 ys treated in the clinic.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00456690
Other Study ID Numbers  ICMJE 5190906/2.EMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr Koren Ariel, HaEmek Medical Center, Israel
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE HaEmek Medical Center, Israel
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carina Levin, MD Pediatric Hematology Unit, Ha'Emek Medical Center
Study Director: Ariel Koren, MD Pediatric Hematology Unit - Ha'Emek Medical Center
PRS Account HaEmek Medical Center, Israel
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP