Vitamin D Supplementation for Reduction of Dyslipidemia in Premenopausal Women
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- serum levels of LDL-HDL-Total cholesterol-triglecerides
研究概览
简要总结
This study will be conducted to Assess possible reduction in lipid profile (LDL-Triglecerides-cholesterol) among pre-menopausal women in vit D group compared to standard treatment group after 3 months & 6 month of follow up as prophylaxis step for atherosclerosis.
详细描述
Vitamin D receptor gene mutations have been associated with increased incidence of arterial hypertension. While, hyperlipidemia and lipoprotein oxidation in bone is leading to osteoporosis by inhibiting osteoblastic differentiation It has been reported that vitamin D supplementation has shown pro-atherogenic effects in rats, and its deficiency is associated with the deterioration of atherogenesis These contradictory findings on the progression of atherosclerosis were examined in this study.
Aim: This study will be conducted to assess possible reduction in lipid profile (LDL-Triglycerides-cholesterol) among pre-menopausal women in vitamin D group compared to standard treatment group after 3 months & 6 month of follow up as prophylaxis step for atherosclerosis.
Subject and methods: Randomized clinical trial with double blinding will be performed on two groups study group and control group. The cases will recruited from outpatient clinic of medicine department in Mansoura university Hospital.
Sample size: based on pilot study after start of trial
Study groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blinded
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •premenopausal females (35-45 years)
排除标准
- •no co morbodity
- •no lipid lowering drugs or contraceptive pills
研究组 & 干预措施
Treatment
Single high dose IM VIT D
干预措施: Vitamin D3 (Treatment) (Drug)
Control
Usual diet mix of carbohydrates - lipid - protein - minerals & vitamins
干预措施: Mixed diet of carbohydrate and protein (Control) (Other)
结局指标
主要结局
serum levels of LDL-HDL-Total cholesterol-triglecerides
时间窗: 3 months-6 months
reduction in lipid profile significantly than controls
次要结局
未报告次要终点
研究者
Eman Khashaba
Lecturer in Industrial Medicine
Mansoura University