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Completed

NCT Number: NCT01976676

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

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.

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Key information

Conditions

Recurrent Abortion Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5-methyltetrahydrofolate

Dietary Supplement

Folic Acid

Dietary Supplement

Primary outcomes

  1. ongoing pregnancy on the 20th week of gestational age

    Time frame: 20th week of gestational age

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 6, 2013
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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