NCT01976676

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2011

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

2.8 years

First QC Date

October 30, 2013

Last Update Submit

June 14, 2015

Conditions

Recurrent Abortion

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy on the 20th week of gestational age

    20th week of gestational age

Secondary Outcomes (2)

  • serum concentration of folate

    at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age

  • Serum concentration of Homocystein

    at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age

Study Arms (2)

5-methyltetrahydrofolate

EXPERIMENTAL

1 mg 5-methyltetrahydrofolate per day

Dietary Supplement: 5-methyltetrahydrofolate

folic acid

ACTIVE COMPARATOR

1 mg Folic acid per day

Dietary Supplement: folic Acid

Interventions

5-methyltetrahydrofolateDIETARY_SUPPLEMENT
5-methyltetrahydrofolate
folic AcidDIETARY_SUPPLEMENT
folic acid

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26630680DERIVED

MeSH Terms

Conditions

Abortion, Habitual

Interventions

5-methyltetrahydrofolateFolic Acid

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 6, 2013

Study Start

April 1, 2011

Primary Completion

February 1, 2014

Study Completion

September 1, 2014

Last Updated

June 16, 2015

Record last verified: 2015-06