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

Phase 4RecruitingNCT06508242

Fondazione Policlinico Universitario Campus Bio-Medico80 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Musculoskeletal Diseases Inflammation Sarcopenic Obesity

Interventions

CholecalciferolDRUG

cholecalciferol

PlaceboOTHER

placebo

Eligibility

Sex: ALLMin age: 55 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione Policlinico Universitario Campus Bio-Medico di Roma

Roma, RM, Italy

RECRUITING

Outcomes

Primary Outcomes

WNT pathway regulation

Specifically, WNT10b, WNT5a, sFRP5, pGSK-3ß-Ser9 and total GSK-3ß expression will be evaluated and subsequently confirmed by RT-PCR and Western-blot analysis on adipose and muscle tissue. Serum sclerostin,DDK-1 and sFRP5 will be also evaluated by ELISA

Time frame: from 6 to 30 months

Secondary Outcomes

Muscle strength and function

• Gene involved in myogenesis will be analyzed by RT-PCR (Relative Expression) and Western-blot (Relative Abundance).