Clinical Trial: Folic Acid vs 5-methyltetrahydrofolate (5MTHF) in Recurrent Abortion

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary:
Sponsor: National Nutrition and Food Technology Institute

Current Primary Outcome: ongoing pregnancy on the 20th week of gestational age [ Time Frame: 20th week of gestational age ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • serum concentration of folate [ Time Frame: at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age ]
  • Serum concentration of Homocystein [ Time Frame: at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age ]


Original Secondary Outcome: serum concentration of folate and Homocystein [ Time Frame: at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age ]

Information By: National Nutrition and Food Technology Institute

Dates:
Date Received: October 30, 2013
Date Started: April 2011
Date Completion:
Last Updated: June 14, 2015
Last Verified: June 2015