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临床试验/NCT03310307
NCT03310307已完成2 期

Vitamin D3 Treatment Decreases Serum Total Homocysteine Concentrations of Overweight Reproductive Women: Randomized Placebo Controlled Clinical Trail

Al-Balqa Applied University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

50,000 IU

干预措施: Vit D (Drug)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nahla Bayyari

Assistant Professor

Al-Balqa Applied University

研究点 (1)

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