Endocrine and Nutritional Assessment in B Thalassemia Major | NCT00456690

Studies
Endocrine and Nutritional Assessment in B Thalassemia Major

NCT00456690

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Nov 1, 2019Actual

Enrollment

133Actual

Phase

Not Applicable

Conditions

Thalassemia

Interventions

Nutritional recommendations

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 4, 2007

First Submission Date that Met QC Criteria

Apr 4, 2007

First Posted Date

Apr 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2019

Last Update Posted Date

Nov 1, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, IsraelPrincipal Investigator

Lead Sponsor

HaEmek Medical Center, IsraelOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

133Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Thalassemia Mayor Patients	Other: Nutritional recommendations

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutritional recommendations	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

Measure	Description	Time Frame
BMI		1 year study

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients above age 5 ys treated in the clinic.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carina Levin, MD	Pediatric Hematology Unit, Ha'Emek Medical Center	Principal Investigator
Ariel Koren, MD	Pediatric Hematology Unit - Ha'Emek Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Hematology Unit - HaEmek Medical Center		Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D013789	Thalassemia

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided