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

Phase 2

Completed

• Conditions: Recurrent Abortion
• Interventions: Dietary Supplement: 5-methyltetrahydrofolate; Dietary Supplement: folic Acid

• Registration Number: NCT01976676
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2014-02
• Study Completion: 2014-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-14
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-methyltetrahydrofolate	5-methyltetrahydrofolate	1 mg 5-methyltetrahydrofolate per day
folic acid	folic Acid	1 mg Folic acid per day

Primary Outcome Measures

Name	Time	Method
ongoing pregnancy on the 20th week of gestational age	20th week of gestational age

Secondary Outcome Measures

Name	Time	Method
Serum concentration of Homocystein	at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age
serum concentration of folate	at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age