Clinical trial NCT06508242: Effects Of Vitamin D On Bone, Muscle, And Adipose Tissue In Obese Subjects
Official title: Effects Of Vitamin D On Bone, Muscle, And Adipose Tissue In Obese Subjects: A Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Musculoskeletal Diseases
Inflammation
Sarcopenic Obesity
Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: 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.

Primary outcomes:
measure: WNT pathway regulation
timeFrame: from 6 to 30 months
Secondary outcomes:
measure: Muscle strength and function
timeFrame: from 0 to 32 months
measure: Muscle strength and function
timeFrame: from 0 to 32 months
measure: Muscle strength and function
timeFrame: from 0 to 32 months
measure: Muscle strength and function
timeFrame: from 0 to 32 months
measure: Muscle strength and function
timeFrame: from 0 to 32 months
measure: Muscle strength and function
timeFrame: from 0 to 32 months
measure: Muscle strength and function
timeFrame: from 0 to 32 months
measure: Muscle strength and function
timeFrame: from 0 to 32 months
measure: Effects of inflammation and WNT pathway on adipose tissue
timeFrame: from 0 to 32 months
measure: Effects of inflammation and WNT pathway on adipose tissue
timeFrame: from 0 to 32 months
measure: Effects of inflammation and WNT pathway on bone tissue
timeFrame: from 0 to 32 months
measure: Effects of inflammation and WNT pathway on bone tissue
timeFrame: from 0 to 32 months
measure: Effects of inflammation and WNT pathway on bone tissue
timeFrame: from 0 to 32 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma
state: RM
Study officials:
References: