Comparison of the Effect of Folic Acid and 5-methyltetrahydrofolate (5MTHF) on Serum Folate and Homocysteine Levels, and Abortion Rates in Women Suffering From Recurrent Abortion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 主要终点
- ongoing pregnancy on the 20th week of gestational age
研究概览
简要总结
Recent data indicates that 5 methyltetrahydrofolate (5MTHF) can reduce serum homocystein level more efficiently than folic acid. On the other hand, folic acid is currently an important part of treatment in idiopathic recurrent abortion. There is no study comparing the effectiveness of these supplements in the treatment of recurrent abortion. The aim of this study is to compare the efficiency of these two agents in the treatment of recurrent abortion. In this study, patients with idiopathic recurrent abortion, referring to Avicenna clinic will be randomly allocated into two groups of those taking either folic acid (5 mg) or 5 MTHF (5mg) from 8 weeks prior to conception until the 20th week of pregnancy. The serum level of folate, homocystein, and ongoing pregnancy will be analysed and compared in the two 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in the study and filling out the informed consent form,
- •History of 3 or more idiopathic abortion,
- •the last abortion should be more than 6 months ago,
- •no history of consumption of folate supplements or high folate containing foods during last 6 months,
- •All previous abortions should be idiopathic without any anatomic, cytologic, hormonal, septic pathologic finding,
- •no special diets
排除标准
- •elective or induced abortion, molar or ectopic pregnancies,
- •presence of any malignancy, chromosomal abnormality, uterine abnormality, Thyroid, kidney, or liver dysfunction, Glucose intolerance, seizure,
- •Alcohol or drug abuse,
- •Taking any drug affecting homocystein metabolism,
- •not following the study protocol.
结局指标
主要结局
ongoing pregnancy on the 20th week of gestational age
时间窗: 20th week of gestational age
次要结局
- Serum concentration of Homocystein(at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age)
- serum concentration of folate(at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age)
研究者
Dr Azita Hekmatdoost
Associate Prof
National Nutrition and Food Technology Institute