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

NCT06508242 | Recruiting Phase 4

• 1 other identifier: 73.20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Diseases; Inflammation; Sarcopenic Obesity

Outcome Measures

Primary Outcomes (1)

• 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

  from 6 to 30 months

Secondary Outcomes (13)

• Muscle strength and function

  from 0 to 32 months

• Muscle strength and function

  from 0 to 32 months

• Muscle strength and function

  from 0 to 32 months

• Muscle strength and function

  from 0 to 32 months

• Muscle strength and function

  from 0 to 32 months

Study Arms (2)

Vitamin D intervention group

ACTIVE COMPARATOR

50.000 IU of oral cholecalciferol/week

Drug: Cholecalciferol

Placebo group

PLACEBO COMPARATOR

Placebo treatment/week

Other: Placebo

Interventions

Cholecalciferol DRUG

cholecalciferol

Vitamin D intervention group

Placebo OTHER

placebo

Placebo group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico di Roma

Roma, RM, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases; Inflammation

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Nicola Napoli, PhD

CONTACT

+3906225419151; N.Napoli@policlinicocampus.it

Flavia Tramontana, PhD

CONTACT

+3906225419152; f.tramontana@unicampus.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: July 18, 2024
• Study Start: April 28, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-03

Locations

IT (1)