The effects of vitamin D on bone, muscle and adipose tissue: a phase IV randomized double-blind study.

Phase 1

Active, not recruiting

Conditions: Obese patients with vitamin D deficiency who have scheduled either hip replacement due to osteoarthritis or bariatric surgery.
MedDRA version: 20.0Level: PTClassification code 10047626Term: Vitamin D deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2019-003907-37-IT

Lead Sponsor: IVERSITÀ CAMPUS BIO-MEDICO DI ROMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Availability to comply with the requirements of the protocol as reported in the written informed consent;
2. Post-menopausal women between 55 and 75 years of age and men of equal age for whom one of the two surgical procedures has been scheduled.
3. BMI >_ 30 kg / m2
4. Levels of 25 (OH) D <20 ng / ml
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. eGFR <40 ml / min. / 1.72 m2 estimated by the EPI formula (8)
2. Hypercalcaemia (> 10.5 mg / dL)
3. Nephrolithiasis known to the anamnesis
4. Conditions that can alter the metabolism of calcium and vitamin D (primary hyperparathyroidism, hyperthyroidism, chronic renal failure, liver failure, hypercortisolism, malabsorption, HIV);
5. Use of drugs that can alter bone metabolism (estrogen, raloxifene, tamoxifen, bisphosphonates, denosumab, teriparatide, GnRH analogues, use of at least 5 mg per day of glucocorticoids for = 3 months, anabolic steroids, dilantin, antiretrovirals, therapy radiant);
6. Immobilized patients;
7. Alcohol and / or tobacco abuse;
8. Clinical history of bone metastases or neoplastic bone diseases;
9. Paget's disease;
10. Pathologies at the surgical site;
11. Participation in interventional clinical studies in the past 3 months;
12. Hypersensitivity to cholecalciferol or to any of the excipients.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the effect on inflammation of cholecalciferol supplementation in obese patients with vitamin D deficiency.;Secondary Objective: Evaluate the inflammatory processes of muscle and adipose tissue following supplementation with cholecalciferol; evaluate the effects of cholecalciferol supplementation on the modulation of the WNT pathway in bone, muscle and adipose tissue in obese subjects; evaluate the safety of cholecalciferol supplementation;Primary end point(s): Serum: Changes in the pro-inflammatory cytokine TNF-a will be evaluated by ELISA;Timepoint(s) of evaluation of this end point: Beginning (T0), during (T1) and at the end of the study (T2)

Secondary Outcome Measures