Effects of Vitamin D on bone, muscle, and fat in obese individuals

Effects Of Vitamin D On Bone, Muscle, And Adipose Tissue In Obese Subjects: A Randomized, Double-Blind, Placebo-Controlled Study

This study tests if taking vitamin D can help improve bone, muscle, and fat health in obese adults who don't have enough of it.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 55 Years to 75 Years
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico (Academic / other)
• Drugs / interventions: denosumab
• Locations: 1 site (Roma, RM)
• Trial ID: NCT06508242 on ClinicalTrials.gov

What this trial studies

This study investigates how vitamin D supplementation can improve bone, muscle, and adipose tissue health in obese adults who are vitamin D deficient. It employs a double-blind, placebo-controlled design to assess the effects of cholecalciferol on the Wnt signaling pathway, which is linked to the health of these tissues. The study aims to evaluate changes in muscle mass and strength, as well as vitamin D levels, through different administration strategies. Participants will include post-menopausal women and age-matched men with specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are post-menopausal women aged 55-75 and age-matched men with a BMI of 30 or higher and low vitamin D levels.

Not a fit: Patients with severe kidney issues, osteoporosis, or those on medications affecting bone metabolism may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment recommendations for vitamin D deficiency in obese individuals, potentially improving their musculoskeletal health.

How similar studies have performed: Other studies have shown promising results with vitamin D supplementation in improving musculoskeletal health, but this specific approach focusing on the Wnt pathway is novel.

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.

Where this trial is running

Roma, RM

• Fondazione Policlinico Universitario Campus Bio-Medico di Roma — Roma, Rm, Italy (Recruiting)

Study contacts

• Study coordinator: Nicola Napoli, PhD

Conditions Musculoskeletal Diseases; Inflammation; Sarcopenic Obesity