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临床试验/NCT04005573
NCT04005573已完成不适用

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

Applied Science Private University1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2019年7月10日最近更新:
适应症

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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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