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

NCT06508242 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-07-18

No results posted yet for this study

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

Interventions

DRUG

Cholecalciferol

cholecalciferol

OTHER

Placebo

placebo

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Campus Bio-Medico

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-28
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06508242 on ClinicalTrials.gov