Vitamin D and Adipose Tissue: Storage or Sequestration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change from Baseline of height measurements at 6 months
研究概览
简要总结
The goal of this observational study is to verify the role of adipose tissue in determining the vitamin D serum level after monthly oral administration in subjects with vitamin D deficiency.
The main questions it aims to answer are:
- Adipose tissue represents a storage environment for vitamin D or it's an environment where vitamin D is sequestered and no longer released
- On the other hands, it's possible to verify whether the adipose tissue carries out a bi-modal activity towards vitamin D
- If adipose tissue exerts a bi-modal effect, it is possible to identify a specific threshold between the two effects Participants will undergo anthropometric measurements (height, weight, waist/hip ratio waist circumference) at baseline and after 6 months of intake of cholecalciferol 50,000 IU/month
详细描述
Vitamin D deficiency and insufficiency are prevalent worldwide, and various factors contribute to their occurrence, including low sun exposure, poor dietary intake, obesity, and abdominal obesity. Abdominal obesity, assessed by waist circumference (WC), is associated with metabolic syndrome and has been linked to low vitamin D levels. This study aimed to investigate the relationship between visceral adipose tissue (VAT) and vitamin D levels, particularly examining the potential threshold for vitamin D storage and sequestration by adipose tissue.
The study is conducted on patients with hypovitaminosis D in an internal medicine outpatient department. Blood samples for the evaluation of calcium and vitamin D levels are collected at baseline and after six months of monthly cholecalciferol supplementation. Ultrasonography are used to evaluate adipose tissue measurements, including subcutaneous adipose tissue thickness, VAT, preperitoneal adipose tissue (PPAT), and prerenal adipose tissue (PRAT). Anthropometric measures such as waist-to-hip ratio and waist-to-height ratio are also assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vitamin D level < 20 ng/ml
- •BMI > 24
排除标准
- •Administration of vitamin D metabolites in the last year
- •Previous diagnosis of metabolic bone diseases
- •Previous diagnosis of endocrine diseases
- •Previous diagnosis of cancer
结局指标
主要结局
Change from Baseline of height measurements at 6 months
时间窗: 6 months
height expressed in cm
Change from Baseline of weight at 6 months
时间窗: 6 months
weight expressed in Kg
Change from Baseline of vitamin D levels at 6 months
时间窗: 6 months
blood sample expressed in ng/ml
Change from Baseline of waist and hip circumference at 6 months
时间窗: 6 months
waist and hip circumference expressed in centimeters
Change from Baseline of body adipose tissue at 6 months
时间窗: 6 months
body adipose index expressed in percentage
Change from Baseline of ultrasound adipose tissue measurement at 6 months
时间窗: 6 months
visceral, subcutaneous, pre-renal, pre-peritoneal adipose tissue expressed in millimeters
次要结局
- Change from Baseline of calcium levels at 6 months(6 months)
研究者
Luca Giuseppe Dalle Carbonare
Associate Professor
Azienda Ospedaliera Universitaria Integrata Verona