Assessment of Nutritional Status and Role of Insulin-like Growth Factor-1 in Children

September 2, 2022 updated by: Samar Abdelhameed, Menoufia University

Assessment of Nutritional Status and Role of Insulin-like Growth Factor-1 in Children With Thalassemia Major

Many studies done on children with thalassemia have shown a variable prevalence of defective IGF-I concentrations have been shown to be low in the majority of children, with or without GH deficiency. The Aim of this study to assess nutritional status and role of Insulin-like growth factor 1 (IGF-1) and its associating factors in children with thalassemia major

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

102

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

  • Egypt
      • Shibīn Al Kawm, Egypt
        • Samar Abd El-Hameed

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

4 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

67 Children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia, and 35 healthy control

Description

Inclusion Criteria:

  • Children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia major.

Exclusion Criteria:

  • Children with other chronic diseases (cardiac, renal, vascular)
  • Children with malignancy

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

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Patients
67 children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia major.
Healthy control
35 healthy children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IGF-1
Time Frame: at the time of recruitment
insulin-like growth factor-1 which measured by enzyme linked immunosorbent assay (ELISA).
at the time of recruitment

Collaborators and Investigators

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

Sponsor

Menoufia University

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 (Actual)

October 1, 2020

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • insulin-like growth factor-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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