Effects Of Vitamin D On Bone, Muscle, And Adipose Tissue In Obese Subjects: A Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- WNT pathway regulation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Vitamin D intervention group
50.000 IU of oral cholecalciferol/week
干预措施: Cholecalciferol (Drug)
Placebo group
Placebo treatment/week
干预措施: Placebo (Other)
结局指标
主要结局
WNT pathway regulation
时间窗: from 6 to 30 months
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
次要结局
- Effects of inflammation and WNT pathway on adipose tissue(from 0 to 32 months)
- Effects of inflammation and WNT pathway on bone tissue(from 0 to 32 months)
- Muscle strength and function(from 0 to 32 months)