Vitamin D Deficiency and Body Composition in the Patients With Hemophilia

NCT05517070 | Completed

• 1 other identifier: 1-108-05-001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Sarcopenia; Osteoporosis; Body Composition; Hemophilic Arthropathy; Hemophilia

Outcome Measures

Primary Outcomes (1)

• Vitamin D

  serum vitamin D

  one day

Secondary Outcomes (5)

• Bone marrow density

  one day

• Body composition

  one day

• Pettersson score

  one day

• Hemophilia Joint Health Score

  one day

• Handgrip strength

  one day

Study Arms (2)

Hemophilia Group

Hemophilia adult patients

Control Group

Healthy adult subjects

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 hemophilia patients and 20 healthy subjects

You may qualify if:

• Hemophilia patients

You may not qualify if:

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

Sponsors & Collaborators

• Tsung-Ying Li: lead

Study Sites (1)

Hemophilia care and research center

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Sarcopenia; Osteoporosis; Hemophilia A

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tsung Ying Li, Dr

  No.325,Sec.2, Cheng-Kung Rd. Neihu 11490, Taipei, Taiwan, R.O.C

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)