Recurrent AbortionPhase 2/3NCT01976676
Folic Acid vs 5-methyltetrahydrofolate (5MTHF) in Recurrent Abortion
A Phase 2/3 study testing 5-methyltetrahydrofolate and folic Acid in people with Recurrent Abortion, run by National Nutrition and Food Technology Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Recurrent Abortion
- What is being tested?
- 5-methyltetrahydrofolate and folic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Sep 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Recurrent Abortion
- Being tested
- 5-methyltetrahydrofolate, folic Acid
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-methyltetrahydrofolateDietary supplement
folic AcidDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 5-methyltetrahydrofolate | Experimental | 1 mg 5-methyltetrahydrofolate per day Receives: Dietary Supplement: 5-methyltetrahydrofolate |
| folic acid | Active comparator | 1 mg Folic acid per day Receives: Dietary Supplement: folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy on the 20th week of gestational age
Measured: 20th week of gestational age
Secondary outcomes (2)
serum concentration of folate
Measured: at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age
Serum concentration of Homocystein
Measured: at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startApr 2011
- Primary completionFeb 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976676
- Sponsor's protocol ID
- 1157
- Status last verified
- Jun 2015
- First submitted
- 30 Oct 2013
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26630680
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01976676
- Acronym / sponsor ID
- 1157
- Conditions
- Recurrent Abortion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-methyltetrahydrofolate | Experimental | Dietary Supplement: 5-methyltetrahydrofolate1 mg 5-methyltetrahydrofolate per day |
| folic acid | Active comparator | Dietary Supplement: folic Acid1 mg Folic acid per day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-methyltetrahydrofolate | Dietary supplement | 5-methyltetrahydrofolate |
| folic Acid | Dietary supplement | folic acid |
Primary outcome
ongoing pregnancy on the 20th week of gestational age
Time frame: 20th week of gestational age
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
- Derived from this study: PubMed 26630680Hekmatdoost 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 5-methyltetrahydrofolate and folic Acid in people with Recurrent Abortion, run by National Nutrition and Food Technology Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ongoing pregnancy on the 20th week of gestational age (time frame: 20th week of gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01976676, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.