Folic Acid vs 5-methyltetrahydrofolate (5MTHF) in Recurrent Abortion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:
NCT01976676
First received: October 30, 2013
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Recurrent Abortion
Dietary Supplement: 5-methyltetrahydrofolate
Dietary Supplement: folic Acid
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Nutrition and Food Technology Institute:

Primary Outcome Measures:
  • ongoing pregnancy on the 20th week of gestational age [ Time Frame: 20th week of gestational age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: May 2012
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-methyltetrahydrofolate
1 mg 5-methyltetrahydrofolate per day
Dietary Supplement: 5-methyltetrahydrofolate
Active Comparator: folic acid
1 mg Folic acid per day
Dietary Supplement: folic Acid

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr Azita Hekmatdoost, Associate Prof, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT01976676     History of Changes
Other Study ID Numbers: 1157
Study First Received: October 30, 2013
Last Updated: November 6, 2013
Health Authority: Iran:Food and Drug Administration

Additional relevant MeSH terms:
Pregnancy Complications
Folic Acid
Vitamin B Complex
Abortion, Habitual
Abortion, Spontaneous
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014