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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
RECRUITING
Roma
Contact Information
Primary
Nicola Napoli, PhD
N.Napoli@policlinicocampus.it
+3906225419151
Backup
Flavia Tramontana, PhD
f.tramontana@unicampus.it
+3906225419152
Time Frame
Start Date: 2023-04-28
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Vitamin D intervention group
50.000 IU of oral cholecalciferol/week
Placebo_comparator: Placebo group
Placebo treatment/week
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Campus Bio-Medico

This content was sourced from clinicaltrials.gov

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