Clinical trial NCT05517070: Vitamin D Deficiency and Body Composition in the Patients With Hemophilia
Official title: Association of Vitamin D Deficiency, Sarcopenia, Body Composition, Osteoporosis and Hemophilic Arthropathy in the Patients With Hemophilia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Sarcopenia
Osteoporosis
Body Composition
Hemophilic Arthropathy
Hemophilia
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 hemophilia patients and 20 healthy subjects

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Vitamin D
timeFrame: one day
Secondary outcomes:
measure: Bone marrow density
timeFrame: one day
measure: Body composition
timeFrame: one day
measure: Pettersson score
timeFrame: one day
measure: Hemophilia Joint Health Score
timeFrame: one day
measure: Handgrip strength
timeFrame: one day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Hemophilia care and research center
Study officials:
affiliation: No.325,Sec.2, Cheng-Kung Rd. Neihu 11490, Taipei, Taiwan, R.O.C
name: Tsung Ying Li, Dr
role: PRINCIPAL_INVESTIGATOR
References: