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

Recurrent Abortion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976676
• Other study ID #: 1157
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 30, 2013
• Last updated: June 14, 2015
• Start date: April 2011
• Est. completion date: September 2014

Study information

• Verified date: June 2015
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran:Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Habitual
• Recurrent Abortion

Intervention

Dietary Supplement:
• 5-methyltetrahydrofolate

• folic Acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ongoing pregnancy on the 20th week of gestational age		20th week of gestational age	No
Secondary	serum concentration of folate		at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age	No
Secondary	Serum concentration of Homocystein		at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age	No