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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01976676
Recruitment Status : Completed
First Posted : November 6, 2013
Last Update Posted : June 16, 2015
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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.

Condition or disease Intervention/treatment Phase
Recurrent Abortion Dietary Supplement: 5-methyltetrahydrofolate Dietary Supplement: folic Acid Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 5-methyltetrahydrofolate
1 mg 5-methyltetrahydrofolate per day
Dietary Supplement: 5-methyltetrahydrofolate
Active Comparator: folic acid
1 mg Folic acid per day
Dietary Supplement: folic Acid

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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • 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

Exclusion Criteria:

  • 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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Azita Hekmatdoost, Associate Prof, National Nutrition and Food Technology Institute Identifier: NCT01976676     History of Changes
Other Study ID Numbers: 1157
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Pregnancy Complications
Folic Acid
Vitamin B Complex
Abortion, Habitual
Abortion, Spontaneous
Growth Substances
Physiological Effects of Drugs