Comparison of the effect of folic acid and 5-methyltetrahydrofolate (5MTHF) on serum folat and homocysteine levels, and abortion rates in women suffering from recurrent abortion
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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903034010N1
Registration date:2010-06-22, 1389/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-22, 1389/04/01
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Research Institute and National nutrition research institute
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of folic acid and 5-methyltetrahydrofolate (5MTHF) on serum folat and homocysteine levels, and abortion rates in women suffering from recurrent abortion
Public title
Comparison of the effect of folic acid and 5-methyltetrahydrofolate (5MTHF) on serum folat and homocysteine levels, and abortion rates in women suffering from recurrent abortion
Purpose
Treatment
Inclusion/Exclusion 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 one should be more than 6 months ago, no history of intaking 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.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Ethics Committee
Street address
Avicenna Reserch Institute
City
Tehran
Postal code
Approval date
2009-09-23, 1388/07/01
Ethics committee reference number
55
Health conditions studied
1
Description of health condition studied
recurrent abortion
ICD-10 code
O03
ICD-10 code description
spontaneous abortion
Primary outcomes
1
Description
changes in recurrent abortion successful treatment