Vitamin D3 Treatment Decreases Serum Total Homocysteine Concentrations of Overweight Reproductive Women: Randomized Placebo Controlled Clinical Trail
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 25(OH)D3
研究概览
简要总结
100 overweight reproductive vitamin D deficient women were divided into two groups; vitamin D (n = 50) and placebo (n = 50). Vitamin D group received treatment dose of 50,000 IU of vitamin D3 per week for 2 consecutive months and placebo group received placebo tablets similar in size, shape and color to vitamin D3 for 2 months also. Total homocysteine concentrations were measured before intervention (basal), on 30 days (one month) and on 60 days (2 months) of intervention. Changes in means of homocysteine concentrations for placebo and vitamin D group over time showed significant difference on 30 and 60 days of intervention. Mean comparisons of homocysteine concentrations and standard error of the means before and after intervention showed statistical significant decrease in homocysteine concentrations among vitamin D group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 49 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Overweight (BMI between 25-29.99 kg/m2)
- •Had 25(OH)D < 20 ng/mL
- •Had normal vitamin B-12 and folic acid levels
- •Not diagnosed with any chronic diseases
- •Agreed to participat in the study
排除标准
- •age < 18 or > 49 years
- •BMI > 30 kg/m2 or < 25 kg/m2
- •25 (OH)D level > 20 ng/ml
- •tHcy levels greater than 100 µmol/L
- •Abnormal vitamin B-12 or folic acid levels
- •Chronic diseases
- •Pregnant or lactating
研究组 & 干预措施
vitamin D3
50,000 IU
干预措施: Vit D (Drug)
Placebo
Similar in size, shape and color to vitamin D3
干预措施: Placebo (Other)
结局指标
主要结局
25(OH)D3
时间窗: 2 months
vitamin D in serum
次要结局
- Homocysteine(2 months)
研究者
Nahla Bayyari
Assistant Professor
Al-Balqa Applied University
