Effects Of Vitamin D On Bone, Muscle, And Adipose Tissue In Obese Subjects

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO CAMPUS BIO-MEDICO · Jul 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how vitamin D affects bone, muscle, and fat tissue health in people who are obese and have low levels of vitamin D. Researchers believe that vitamin D might help improve these areas by influencing a specific biological pathway related to bone and muscle health. The study involves giving vitamin D supplements to participants and observing how these supplements impact their bone strength, muscle mass, and overall health.

To participate, you need to be a post-menopausal woman aged 55 to 75, or a man of the same age group, with a body mass index (BMI) of 30 or higher and low vitamin D levels. You should be able to walk and provide consent for the study. If you have certain health conditions, such as severe kidney problems or osteoporosis, you may not be eligible. Participants will receive vitamin D supplements in different schedules and will be monitored for changes in their health over time. This trial aims to provide new insights and recommendations for treating vitamin D deficiency in people with obesity, which could ultimately improve their health outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.