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

Phase 3CompletedNCT01976676

National Nutrition and Food Technology Institute220 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

220

Conditions

Recurrent Abortion

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

ongoing pregnancy on the 20th week of gestational age

Time frame: 20th week of gestational age

Secondary Outcomes

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

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