Clinical trial NCT01976676: Folic Acid vs 5-methyltetrahydrofolate (5MTHF) in Recurrent Abortion
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Recurrent Abortion
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: ongoing pregnancy on the 20th week of gestational age
timeFrame: 20th week of gestational age
Secondary outcomes:
measure: serum concentration of folate
timeFrame: at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age
measure: Serum concentration of Homocystein
timeFrame: at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age
Other outcomes:
Locations:
Study officials:
References:
citation: Hekmatdoost A, Vahid F, Yari Z, Sadeghi M, Eini-Zinab H, Lakpour N, Arefi S. Methyltetrahydrofolate vs Folic Acid Supplementation in Idiopathic Recurrent Miscarriage with Respect to Methylenetetrahydrofolate Reductase C677T and A1298C Polymorphisms: A Randomized Controlled Trial. PLoS One. 2015 Dec 2;10(12):e0143569. doi: 10.1371/journal.pone.0143569. eCollection 2015.