NCT05529550

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

September 2, 2022

Last Update Submit

September 2, 2022

Conditions

Thalassemia

Keywords

Insulin-like growth factor 1

Outcome Measures

Primary Outcomes (1)

  • IGF-1

    insulin-like growth factor-1 which measured by enzyme linked immunosorbent assay (ELISA).

    at the time of recruitment

Study Arms (2)

Patients

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

Healthy control

35 healthy children

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samar Abd El-Hameed

Shibīn al Kawm, Egypt

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 Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

October 1, 2020

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations

EG(1)