Status:
RECRUITING
Effects Of Vitamin D On Bone, Muscle, And Adipose Tissue In Obese Subjects
Lead Sponsor:
Fondazione Policlinico Universitario Campus Bio-Medico
Conditions:
Musculoskeletal Diseases
Inflammation
Eligibility:
All Genders
55-75 years
Phase:
PHASE4
Brief Summary
Obesity has emerged as a risk factor in the onset of bone, muscle and adipose tissue impairments that are further aggravated by vitamin D deficiency. A link of an active bone-muscle-adipose axis is re...
Eligibility Criteria
Inclusion
- Ambulatory willing and able to provide informed consent;
- post-menopausal women (55-75 y.o.) and age-matched men;
- BMI 30 \>= kg/m2;
- serum 25OHD \< 20 ng/ml
- hip replacement surgery due to osteoarthritis according to orthopedic clinical decision
Exclusion
- eGFR \<40 ml/min/1.72 m2 by EPI formula (21);
- hypercalcemia (\>10.5 mg/dL);
- osteoporosis (hip or vertebral t-score \>-2.5);
- conditions affecting bone
- vitamin D and/or calcium metabolism (chronic liver disease, renal failure, malabsorption, hypercortisolism);
- medications altering bone metabolism (e.g. denosumab, bisphosphonates, teriparatide, glucocorticoids, aromatase inhibitors, estrogen);
- enrollment in an interventional clinical trial in the previous 3 months.
Key Trial Info
Start Date :
April 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06508242
Start Date
April 28 2023
End Date
December 31 2025
Last Update
July 18 2024
Active Locations (1)
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1
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Roma, RM, Italy, 00128