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Effects Of Vitamin D On Bone, Muscle, And Adipose Tissue In Obese Subjects: A Randomized, Double-Blind, Placebo-Controlled Study
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.
Age
55 - 75 years
Sex
ALL
Healthy Volunteers
No
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Roma, RM, Italy
Start Date
April 28, 2023
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2025
Last Updated
July 18, 2024
80
ESTIMATED participants
Cholecalciferol
DRUG
Placebo
OTHER
Lead Sponsor
Fondazione Policlinico Universitario Campus Bio-Medico
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06200207