NCT06508242

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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 represented by Wnt pathway. This study will test the hypothesis that vitamin D improves bone, muscle, and adipose tissue health through a positive modulation of Wnt pathway. It will be carried out a double-blind, placebo-controlled study of cholecalciferol supplementation in vitamin D-deficient obese adults. Specific aims will be: 1) to test the direct effect of vitamin D on Wnt signaling in bone, muscle, and adipose tissue; 2) to evaluate muscle mass and strength; 3) to assess changes in vitamin D status across different administration strategy (weekly, fortnightly, monthly). This study will provide not only insight of new mechanisms involved in the pathophysiology of obesity-related musculoskeletal impairments but also evidence for new treatment recommendations for vitamin D deficiency in obesity.

Conditions

• Musculoskeletal Diseases
• Inflammation
• Sarcopenic Obesity

Interventions

Type	Name	Description
DRUG	Cholecalciferol	cholecalciferol
OTHER	Placebo	placebo

Timeline

• Start date: 2023-04-28
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-07-18
• Last updated: 2024-07-18

Locations

1 site across 1 country: Italy