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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-28

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Musculoskeletal Diseases Inflammation Sarcopenic Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double-blind

Study Groups

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Vitamin D intervention group

50.000 IU of oral cholecalciferol/week

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

cholecalciferol

Placebo group

Placebo treatment/week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo

Interventions

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Cholecalciferol

cholecalciferol

Intervention Type DRUG

Placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No