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Vitamin D Deficiency and Body Composition in the Patients With Hemophilia

T

Tsung-Ying Li

Status

Completed

Conditions

Osteoporosis
Vitamin D Deficiency
Hemophilic Arthropathy
Sarcopenia
Hemophilia
Body Composition

Study type

Observational

Funder types

Other

Identifiers

NCT05517070
1-108-05-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Male

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Hemophilia patients

Exclusion criteria

  • Severe diseases affecting bone metabolism (such as primary hyperparathyroidism, hypogonadism),
  • History of total hip arthroplasty
  • History of instrumentation in lumbar spine

Trial design

80 participants in 2 patient groups

Hemophilia Group
Description:
Hemophilia adult patients
Control Group
Description:
Healthy adult subjects

Trial contacts and locations

1

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Central trial contact

Tsung Ying Li, Dr

Data sourced from clinicaltrials.gov

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