Anthropometric Measurements in Children Having Transfusion-dependent Beta Thalassemia

NCT03947632 | Completed

• 1 other identifier: 2305-Pat-ERC-12
• Study Type: observational
• Target: 367
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to determine the anthropometric measurements in transfusion-dependent β-thalassemia children in Pakistan. The secondary aim was to correlate serum ferritin with the physical growth

Conditions

Beta Thalassemia Major

Outcome Measures

Primary Outcomes (4)

• Height in transfusion-dependent β-thalassemia pediatric patients in Pakistan were recorded to assess growth rate

  Height in meters will be recorded from medical records of the patients

  Jan 2013 to Dec 2014

• Weight in transfusion-dependent β-thalassemia pediatric patients in Pakistan were recorded to assess growth rate

  Wight in kilograms will be recorded from medical records of the patients

  Jan 2013 to Dec 2014

• Assessment of physical growth in transfusion-dependent β-thalassemia pediatric patients in Pakistan were recorded to assess growth rate

  World health organization (WHO) 2007 growth charts were used for boys and girls to assess their physical growth. Body mass index (BMI) was computed as weight in kg/height in square meters (kg/m\^2). z-Score of height (h-SDS), weight (w-SDS), and BMI (BMI-SDS) were also calculated.

  Jan 2013 to Dec 2014

• Serum ferritin levels and their association with z-Score of height

  Correlation was assessed between height for age z-score and serum ferritin levels. Serum ferritin was measured by chemi-luminescent micro-particle immunoassay on Cobos® E-601. The association of z-Score of height with median serum ferritin levels was further confirmed by comparing these laboratory parameters in children with height z-scores \<2 with those with the z-score ≥2 using the Mann-Whitney test.

  Jan 2013 to Dec 2014

Interventions

serum ferritin and hemoglobin test DIAGNOSTIC_TEST

Five milliliter of blood samples were collected in two tubes (ethylenediaminetetraacetic acid and gel) at Fatimid foundation by a trained phlebotomist prior to blood transfusion to determine hemoglobin and serum ferritin.

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

367 pediatric patients (age 5-17 year) with transfusion dependent β-thalassemia were recruited. All patients were diagnosed based on hemoglobin electrophoresis or high-performance liquid chromatography. Patient recruitment was conducted at a non- profit organization named Fatimid Foundation Karachi (FFK), which provides free of cost blood components to the patients with various blood disorders.

You may qualify if:

• Children with transfusion dependent beta thalassemia major
• Age 5 to 17 years
• Subjects with informed consent

You may not qualify if:

• Age more than 17 years
• Subjects who refused informed consent

Sponsors & Collaborators

• Aga Khan University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Five milliliter of blood samples were collected in two tubes (ethylenediaminetetraacetic acid and gel)

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 13, 2019
• Study Start: January 1, 2013
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share