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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003907-37-IT

Enrollment

Registered

2020-10-21

Start date

2020-09-08

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese elderly patients with vitamin D deficiency who have scheduled either hip replacement due to osteoarthritis or bariatric surgery. MedDRA version: 20.0 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Dibase Product Name: Dibase Pharmaceutical Form: Oral solution INN or Proposed INN: colecalciferolo (vitamina D3) CAS Number: 67-97-0 Other descriptive name: VITAMIN D Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1. eGFR 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the effect on inflammation of cholecalciferol supplementation in obese elderly patients with vitamin D deficiency.;Secondary Objective: Evaluate the inflammatory processes of muscle and adipose tissue following cholecalciferol supplementation; evaluate the effects of cholecalciferol supplementation on the modulation of the WNT pathway in bone, muscle and adipose tissue in obese elderly 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)	—

Measure

Time frame

Main Objective: Evaluate the effect on inflammation of cholecalciferol supplementation in obese elderly patients with vitamin D deficiency.;Secondary Objective: Evaluate the inflammatory processes of muscle and adipose tissue following cholecalciferol supplementation; evaluate the effects of cholecalciferol supplementation on the modulation of the WNT pathway in bone, muscle and adipose tissue in obese elderly 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)

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Secondary

Measure	Time frame
Secondary end point(s): Muscle tissue: Nuclear magnetic resonance imaging of the ileo-psoas muscle (MRN). Through RT-PCR the gene expression of inflammatory cytokines (IL-6; IL-8; IL-10; TNF-a; MCP-1) eadiponectin, myogenic proteins (myogenin, myo-D, MHC-2) and myostatin and expression of WNT pathway genes such as: WNT10b, WNT5a, GSK-3b and sFRP5. Protein expression analysis will be performed via Western-Blot for the following elements: TNF-a; IL-6, adiponectin, myostatin, WNT10b, WNT5a, GSK-3b and sFRP5. Adipose tissue: Analysis of gene and protein expression of IL-6 cytokines; IL-8; IL-10; TNF-a; IGF-1, of adiponectin, markers inherent in the WNT pathway such as WNT5a, WNT10b, sFRP5 and GSK-3b and of the differentiation factor PPAR-gamma through RT-PCR and Western-Blot, respectively. Bone tissue: RT-PCR will be used to evaluate the expression of the following genes: WNT5a, WNT10b, GSK-3b, SOST, DKK-1 RUNX2, IGF-1 and osteocalcin. Serum: The following cytokines and adipokines will be evaluated by ELISA: IL-6; IL-8; IL-10 and adiponectin as well as bone turnover markers: CTX, P1NP, active and inactive osteocalcin, BSAP. Serum 25-hydroxy-vitamin D concentration will be assessed by radioimmunoassays. WNT pathway biomarkers will be evaluated by ELISA assays such as: serum sclerostin, DKK-1 and sFRP. In order to monitor the safety of cholecalciferol supplementation, the patient will also be subjected to the calcium at each time point of the study. Intra-medullary fat: Intra-medullary fat will be quantified by spectroscopic magnetic resonance imaging (MRS);Timepoint(s) of evaluation of this end point: Beginning (T0), during (T1) and at the end of the study (T2)	—

Measure

Time frame

Secondary end point(s): Muscle tissue: Nuclear magnetic resonance imaging of the ileo-psoas muscle (MRN). Through RT-PCR the gene expression of inflammatory cytokines (IL-6; IL-8; IL-10; TNF-a; MCP-1) eadiponectin, myogenic proteins (myogenin, myo-D, MHC-2) and myostatin and expression of WNT pathway genes such as: WNT10b, WNT5a, GSK-3b and sFRP5. Protein expression analysis will be performed via Western-Blot for the following elements: TNF-a; IL-6, adiponectin, myostatin, WNT10b, WNT5a, GSK-3b and sFRP5. Adipose tissue: Analysis of gene and protein expression of IL-6 cytokines; IL-8; IL-10; TNF-a; IGF-1, of adiponectin, markers inherent in the WNT pathway such as WNT5a, WNT10b, sFRP5 and GSK-3b and of the differentiation factor PPAR-gamma through RT-PCR and Western-Blot, respectively. Bone tissue: RT-PCR will be used to evaluate the expression of the following genes: WNT5a, WNT10b, GSK-3b, SOST, DKK-1 RUNX2, IGF-1 and osteocalcin. Serum: The following cytokines and adipokines will be evaluated by ELISA: IL-6; IL-8; IL-10 and adiponectin as well as bone turnover markers: CTX, P1NP, active and inactive osteocalcin, BSAP. Serum 25-hydroxy-vitamin D concentration will be assessed by radioimmunoassays. WNT pathway biomarkers will be evaluated by ELISA assays such as: serum sclerostin, DKK-1 and sFRP. In order to monitor the safety of cholecalciferol supplementation, the patient will also be subjected to the calcium at each time point of the study. Intra-medullary fat: Intra-medullary fat will be quantified by spectroscopic magnetic resonance imaging (MRS);Timepoint(s) of evaluation of this end point: Beginning (T0), during (T1) and at the end of the study (T2)

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Countries

Italy

Contacts

Public ContactU.O. di Endocrinologia e Diabetolog

Università Campus Bio-Medico

n.napoli@unicampus.it003906225419151

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026