Vitamin D Deficiency and Body Composition in the Patients With Hemophilia

Last updated: August 11, 2024
Sponsor: Tsung-Ying Li
Overall Status: Completed

Phase

N/A

Condition

Osteoporosis

Body Composition

Hemophilia

Treatment

N/A

Clinical Study ID

NCT05517070
1-108-05-001
  • Ages > 20
  • Male
  • Accepts Healthy Volunteers

Study Summary

Hemophilia is associated with osteoporosis and increased prevalence of low bone mineral density (BMD). Many clinical risk factors have been reported, such as hemophilic arthropathy, reduced physical activity, decreased sun exposure, hepatitis C virus infections, vitamin D deficiency, and low body mass index (BMI). There is no data on the prevalence of vitamin D deficiency and low BMD in hemophilia patients in Taiwan or Asia. To the best of our knowledge, no previous studies have reported the prevalence of sarcopenia and correlation with osteoporosis in hemophilia adult patients. The purpose of this study will evaluate the prevalence of vitamin D deficiency, low BMD, sarcopenia and body composition in a cohort of patients with hemophilia in Taiwan.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Hemophilia patients

Exclusion

Exclusion Criteria:

  • Severe diseases affecting bone metabolism (such as primary hyperparathyroidism,hypogonadism),

  • History of total hip arthroplasty

  • History of instrumentation in lumbar spine

Study Design

Total Participants: 80
Study Start date:
January 01, 2021
Estimated Completion Date:
December 31, 2023

Study Description

Hemophilia is associated with osteoporosis and increased prevalence of low bone mineral density (BMD). Soucek et al. reported sarcopenia and low trabecular BMD at the radius in the boys with hemophilia by CT.The severity of hemophilic arthropathy associated with lower BMD, muscle atrophy and obesity has been shown by some studies.

This is a single-center, cross-sectional, observational study. All participants will sign informed consent that fully disclosed the risks and benefits of study participation. The study will be performed at the Hemophilia Care and Research Center. Sixty adult patients (age ≥ 20) with hemophilia and 20 healthy subjects will be enrolled for scanning of the lean tissue, appendicular skeletal muscle mass (ASM), fat mass, lumbar spine and hip BMD by dual-energy X-ray absorptiometry (DXA) and assess serum vitamin D level. We will collect other clinically relevant information, including age, body mass index (BMI), hemophilia type and severity, inhibitor titer, Pettersson score by x-ray, HJHS, handgrip strength, history of HCV or HIV infection and history of fracture.

Connect with a study center

  • Hemophilia care and research center

    Taipei, 114
    Taiwan

    Site Not Available

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