Assessing the Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein: a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- HDL Cholesterol
研究概览
简要总结
The combined effect of omega-3 fatty acid and vitamin D3 on lipid profile levels and oxidized low density lipoprotein: a randomized controlled trial in males and females with vitamin D deficiency
详细描述
Nothing is published in the literature about the combined effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on on lipid profile levels and oxidized low density lipoprotein
This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on lipid profile levels and oxidized low density lipoprotein in Jordanian people with vitamin D deficiency.
This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on on lipid profile levels and oxidized low density lipoprotein
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Jordanian people aged 25-55 medical diagnosis of vitamin D deficiency ( VD <25 ng/ ml)
排除标准
- •Subjects with previously diagnosed with any chronic disease (cardiovascular disease, osteoporosis, cancer, kidney disease, endocrine disorder, thalassemia) or has a documented history of allergic reactions to n-3FA supplementations
研究组 & 干预措施
omega 3- FA group
dietary supplement : omega 3- FA group 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks
干预措施: omega 3- FA (Dietary Supplement)
VD3 and omega 3 FA group
dietary supplement : VD3 and omega-3FA 50000 IU VD3/week for 8 weeks and 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks
干预措施: VD3 and omega- 3FA (Dietary Supplement)
control group
no intervention was given
干预措施: no intervention (Other)
VD3 group
dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks
干预措施: VD3 (Dietary Supplement)
结局指标
主要结局
HDL Cholesterol
时间窗: 8 weeks
serum level of HDL Cholesterol
VD 3
时间窗: 8 weeks
Serum level of 25-hydroxyvitamin D
triglycerides
时间窗: 8 weeks
serum level of triglycerides
Total Cholesterol
时间窗: 8 weeks
serum level of total cholesterol
LDL Cholesterol
时间窗: 8 weeks
serum level of LDL Cholesterol
oxidized LDL
时间窗: 8 weeks
serum level of oxidized LDL
次要结局
- PTH(8 weeks)
- Calcium and Phosphorus(8 weeks)