2025-520869-52-00招募中4 期
The effects of vitamin D on bone, muscle and adipose tissue: a randomized double-blind phase IV study
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月31日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Serum: Changes in the pro-inflammatory cytokine TNF-alpha will be evaluated via ELISA assay.
研究概览
简要总结
To evaluate the effect of cholecalciferol supplementation on inflammation in obese patients with vitamin D deficiency
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Single-center, non-profit, phase IV, randomized, double-blind study
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Obtaining written informed consent
- •Willingness to adhere to the procedures foreseen by the study, as reported in the informed consent
- •Post-menopausal women between the ages of 55 and 75 and men of the same age for whom hip or knee replacement surgery has been scheduled
- •BMI >= 30 kg/m2
- •25(OH)D levels < 20 ng/ml
排除标准
- •eGFR < 40 ml/min./1.72 m2 estimated via EPI formula
- •Osteoporosis (femoral or vertebral t-score > -2.5)
- •Pathologies at the site of surgery
- •Participation in interventional clinical trials in the previous 3 months
- •Hypersensitivity to cholecalciferol or to any of the excipients
- •Hypercalcemia (>10.5 mg/dL)
- •Nephrolithiasis known by medical history
- •Conditions that can alter the metabolism of calcium and vitamin D (primary hyperparathyroidism, hyperthyroidism, chronic renal failure, liver failure, hypercortisolism, malabsorption, HIV)
- •Use of drugs that can alter bone metabolism (estrogens, raloxifene, tamoxifen, bisphosphonates, denosumab, teriparatide, GnRH analogues, use of at least 5 mg per day of glucocorticoids for ≥ 3 months, anabolic steroids, dilantin, antiretrovirals, radiation therapy)
- •Immobilized patients
- •Alcohol and/or tobacco abuse
- •Clinical history of bone metastases or neoplastic bone diseases
- •Paget's disease
结局指标
主要结局
Serum: Changes in the pro-inflammatory cytokine TNF-alpha will be evaluated via ELISA assay.
Serum: Changes in the pro-inflammatory cytokine TNF-alpha will be evaluated via ELISA assay.
次要结局
- Muscle tissue: Nuclear magnetic resonance imaging of the ilio-psoas muscle (MRN). Using RT-PCR, the gene expression of inflammatory cytokines (IL-6; IL-8; IL-10; TNF-; MCP-1) and adiponectin, myogenic proteins (myogenin, myo-D, MHC-2, MYH1/2, mTORC1, STAT3 and myostatin) as well as the expression of WNT pathway genes such as: WNT10b, WNT5a, GSK-3beta and sFRP5
- Adipose tissue: Gene and protein expression analysis of IL-6 cytokines; IL-8; IL-10; TNF-alpha; IGF-1, adiponectin, markers inherent to the WNT pathway such as WNT5a, WNT10b, sFRP5 and GSK-3beta and the differentiation factor PPAR-gamma via RT-PCR and Western-Blot, respectively. RNA transcription will be performed as previously described, as will analysis of exosomes. Adipocytes will be isolated and the supernatant collected for pro- and anti-inflammatory cytokine testing using Luminex technolog
- Bone tissue: RT-PCR will be used to evaluate the expression of the following genes: WNT5a, WNT10b, GSK-3beta, SOST, DKK-1 RUNX2, IGF-1 and osteocalcin. An immunohistochemical analysis will be performed on the bone to analyze the number and location of Teff and Treg cells. Skeletal tissues will be fixed and decalcified to stain slides with specific monoclonal antibodies, such as anti-CD4 and anti-FOXP3, to identify Teff and Treg cells.
- Synovial fluid: Measurement of pro- and anti-inflammatory/metabolic molecules using the Luminex assay as previously described.
- Serum: The following cytokines and adipokines will be evaluated by ELISA assays: IL-6; IL-8; IL-10 and adiponectin as well as bone turnover markers: CTX, P1NP, active and inactive osteocalcin, BSAP. The serum concentration of 25-hydroxy-vitamin D will be evaluated using radioimmunoassays. Biomarkers of the WNT pathway such as: serum sclerostin, DKK-1 and sFRP will be evaluated using ELISA assays.
- In order to monitor the safety of cholecalciferol supplementation, the patient's blood calcium level will also be measured at each time point of the study.
- PBMCs: Thanks to the execution of venous sampling, it will be possible to extract PMBCs to evaluate the frequency and phenotype of T cells. They will be evaluated by multiparametric flow cytometry to study CD4+, CD8+, Treg and TR3-56 T cells. A combination of the following fluorochrome-conjugated monoclonal antibodies will be used: anti-CD45, -CD3, -CD4, -CD8, -CD56, -CD25, -FoxP3, -CD45RA, -CCR7, -PD-1, -CTLA4. Dead cells detected by a viability dye will be excluded.
- PBMCs will be used to separate the two main subsets of T lymphocytes such as CD4+ and CD8+ T cells using a magnetic bead kit. The isolated cells will be cultured and stimulated or not via the TCR receptor; Cell supernatant will be analyzed via Luminex as previously described to measure both pro- and anti-inflammatory cytokines.
- Intramedullary fat: The quantification of intramedullary fat will take place via magnetic resonance spectroscopic (MRS)
研究者
Prof. Nicola Napoli
Scientific
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
研究点 (1)
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