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

June 14, 2015 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ongoing pregnancy on the 20th week of gestational age
Time Frame: 20th week of gestational age
20th week of gestational age

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 14, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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