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

National Nutrition and Food Technology Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Recurrent Abortion

Treatments: Dietary Supplement: 5-methyltetrahydrofolate; Dietary Supplement: folic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01976676

1157

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups

5-methyltetrahydrofolate

Experimental group

Description:

1 mg 5-methyltetrahydrofolate per day

Treatment:

Dietary Supplement: 5-methyltetrahydrofolate

folic acid

Active Comparator group

Description:

1 mg Folic acid per day

Treatment:

Dietary Supplement: folic Acid