A randomized controlled trial on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth

Phase 4

Completed

• Conditions: spina bifida/myelomeningocele; preterm birth; 10029299; 10010273

• Registration Number: NL-OMON39036
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5000

Inclusion Criteria

All women living in the Northern region of the Netherlands of 18 to 45 years old who want to become pregnant within 12 months are eligible for participation in the study.

Exclusion Criteria

Women who had previous offspring with NTD and other women who take high doses of FA for any other reason and women who use FA-antagonists will be excluded from the study.
Further exclusion criteria are:
a) no informed consent given
b) not understanding Dutch
c) already pregnant at time of inclusion or within 4 weeks after start intervention
d) planning to move to an area where the study is not implemented
e) recently or at present using folic acid antagonists or antifolates or other drugs influencing the folic acid metabolism (methotrexaat, pyrimethamine, trimethoprim)
f) being affected by diabetes, megaloblastic anaemia and/or cancer (previous cancer or abnormal PAP smears)
g) being allergic to folic acid or any other ingredient of the pills used in this study
h) take defined dosages of folic acid for directions other than those listed in the above exclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified