Bone Mineral Density and Its Association with Markers of Oxidative Stress in Children and Adolescents with Hemoglobin H with Constant Spring

Not Applicable

• Conditions: Bone mineral density in children and adolescents with transfusion- dependent hemoglobin H with Constant Spring compared with healthy childrenAssociation between oxidative stress biomarkers and BMD

• Registration Number: TCTR20201108001
• Lead Sponsor: Research affairs, Faculty of Medicine, Khon Kaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-08
• Study Completion: 2022-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion criteria for the thalassemia group
1. Ages 10-20 years
2. Diagnosed with hemoglobin H with Constant Spring (Hb H/CS)
3. Diagnosed with transfusion-dependent Hb H/CS requiring regular blood transfusion every 4-6 weeks to raise Hb levels >7 g/dL. Generally, patients with 3 out of the following 5 criteria required red blood cell transfusion: 1) anemic symptoms 2) Hb ≤7 g/dl 3) growth failure 4) marked hepatosplenomegaly 5) homolytic crisis ≥3 episodes/year
4. Height and weight 10-95%tile
5. BMI 10-85%tile
6. Treated and follow up at Khon Kaen University Hospital

The control group includes age and sex-matched healthy children and adolescents.

Exclusion Criteria

Participants with the following conditions will be excluded:
1. Diseases or medications affecting bone and vitamin D metabolism except calcium and vitamin D supplement
2. Pathological fracture
3. Current or recent fractures (<6 months) or wearing prostheses or instruments around the BMD measurement site
4. Deformity of the bone at the BMD measurement site
5. Pregnancy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umbar and total body less head bone mineral density This is a cross-sectional study (only 1 time point - on study visit) dual-energy x-ray absorptiometry,Stable serum oxidative stress biomarker This is a cross-sectional study (only 1 time point - on the study visit) ELISA, fluorometric assay

Secondary Outcome Measures

Name	Time	Method
Serum malondialdehyde This is a cross-sectional study (only 1 time point - on study visit) Fluorometric assay