NCT00456690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
26 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

7.6 years

First QC Date

April 4, 2007

Last Update Submit

October 30, 2019

Conditions

Thalassemia

Keywords

ThalassemiaNutritionEndocrineBMI

Outcome Measures

Primary Outcomes (1)

  • BMI

    1 year study

Study Arms (1)

1

EXPERIMENTAL

Thalassemia Mayor Patients

Other: Nutritional recommendations

Interventions

Nutritional recommendationsOTHER

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

1

Eligibility Criteria

Age5 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hematology Unit - HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Thalassemia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Carina Levin, MD

    Pediatric Hematology Unit, Ha'Emek Medical Center

    PRINCIPAL INVESTIGATOR

  • Ariel Koren, MD

    Pediatric Hematology Unit - Ha'Emek Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Hematology Unit and Pediatric Dpt B

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

May 1, 2007

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

IL(1)