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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

Recruiting
55-75 years
All
Phase 4

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Overview

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.

Eligibility

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.

Study details
    Musculoskeletal Diseases
    Inflammation
    Sarcopenic Obesity

NCT06508242

Fondazione Policlinico Universitario Campus Bio-Medico

15 October 2025

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