Back to resultsFolic Acid vs 5-methyltetrahydrofolate (5MTHF) in Recurrent Abortion
Primary Purpose
Recurrent Abortion
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
5-methyltetrahydrofolate
folic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Abortion
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
5-methyltetrahydrofolate
folic acid
Arm Description
1 mg 5-methyltetrahydrofolate per day
1 mg Folic acid per day
Outcomes
Primary Outcome Measures
ongoing pregnancy on the 20th week of gestational age
Secondary Outcome Measures
serum concentration of folate
Serum concentration of Homocystein
Full Information
NCT ID
NCT01976676
First Posted
October 30, 2013
Last Updated
June 14, 2015
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT01976676
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Abortion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5-methyltetrahydrofolate
Arm Type
Experimental
Arm Description
1 mg 5-methyltetrahydrofolate per day
Arm Title
folic acid
Arm Type
Active Comparator
Arm Description
1 mg Folic acid per day
Intervention Type
Dietary Supplement
Intervention Name(s)
5-methyltetrahydrofolate
Intervention Type
Dietary Supplement
Intervention Name(s)
folic Acid
Primary Outcome Measure Information:
Title
ongoing pregnancy on the 20th week of gestational age
Time Frame
20th week of gestational age
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
26630680
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.
Results Reference
derived
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Folic Acid vs 5-methyltetrahydrofolate (5MTHF) in Recurrent Abortion
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