Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
5000 participants
INTERVENTIONAL
2009-07-31
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The hypothesis that a higher intake of folic acid is related to an higher risk reduction of neural tube defects and of other congenital malformations is the main rationale for the present study.
The present study is a randomized, double-blind, controlled trial evaluating whether supplementation with folic acid at high dose (4 mg/day) reduces the overall risk of major congenital malformations in the population more than the standard recommended dose (0.4 mg/day). At the enrolment visit all the eligible women will be interviewed to assess sociodemographic, life style and health status. After randomization, women will be interviewed every 4 months to evaluate pregnancy status. Women who have a pregnancy diagnosis during the study period will be interviewed by telephone at the expected 16, 24 and 40 weeks of gestation to evaluate the pregnancy outcome. The health status of live births will be evaluated at the child's age of 1 month, 3 months and 1 year.
The primary aim of this project is conducting a study to assess the effect of folic acid periconceptional supplementation of 4 mg/day compared to the 0.4 mg/day standard dose on reducing the occurrence of all congenital malformations. Secondary aims of this study include comparing severity of CMs in offspring of trial mothers, rates of "selected congenital malformations", rates of twinning, miscarriages, recurrent abortions, small-for-gestational age, preeclampsia and abruptio placentae. The sample size is not easy to be computed because lacking robust estimate of the size effect of the treatment. Three hypotheses of a size effect of 45%, 26% and 13% were considered. A sample size of outcomes (and women) respectively of 2,006 (5,015), 8,510 (21,275) and 30,126 (75,315) is needed. Since the sample size needed to evaluate different scenarios is large, the present study is also the pilot study to promote an international prospective meta-analysis.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Folic Acid Supplementation in Pregnant Women: Dose Response
NCT02124642
Efficacy of Weekly Versus Daily Folic Acid Supplementation
NCT00394862
The Effect of High Dose Folic Acid Versus Placebo on the Rate of Gestational Diabetes or Gestational Hypertension in Pregnant Women
NCT01302756
High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention
NCT01355159
Natural Folate vs. Synthetic Folic Acid in Pregnancy
NCT04022135
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
folic acid 4 mg
folic acid
folic acid 0.4 mg
folic acid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
folic acid
folic acid
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* women who intend to become pregnant (not excluded women
Exclusion Criteria
* women planning to move to an area where the study is not ongoing
* women who do not understand and speak Italian
* women who do not have a phone
* women affected by epilepsy, even not assuming anticonvulsivant drugs
* women affected by diabetes
* women who previously had a tumour or a disease relevant for the study (Crohn disease, rheumatoid arthritis, ulcerative colitis)
* women who recently assumed antifolates, like methotrexate
* women who currently abuse or previously abused alcohol
* obese women
* vegetarian women
* women who had a previous pregnancy with neural tube defect (NTD) or any other congenital structural defect
* women or partners with NTD, or one of their relatives with an NTD
* women with positive family history for breast or colorectal cancer
* women with positive family or personal history of hereditary syndrome like adenomatous polyposis, or hereditary nonpolyposis colorectal cancer
* women allergic to folic acid
* women presenting contraindications to folic acid
* women affected by megaloblastic anaemia
* assuming folic acid at defined doses for conditions other than those already mentioned
18 Years
44 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
International Centre of Birth Defects
OTHER
Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Renata Bortolus, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria Integrata Verona
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedale di Adria
Adria, Rovigo, Italy
Ospedale San Luca
Trecenta, Rovigo, Italy
Ospedale di Conegliano
Conegliano, Treviso, Italy
Family Health Centre
Montebelluna, Treviso, Italy
Family Health Practice
Oderzo, Treviso, Italy
Family Health Practice
Villorba, Treviso, Italy
Ospedale Sant'Antonio Abate
Gallarate, Varese, Italy
Family Health Practice
Camponogara, Venezia, Italy
Family Health Centre
Martellago, Venezia, Italy
Family Health Practice
Mira, Venezia, Italy
Family Health Centre
Noale, Venezia, Italy
Family Health Centre
San Pietro di Stra, Venezia, Italy
Family Health Centre
Vogonovo, Venezia, Italy
Ospedale di Bussolengo
Bussolengo, Verona, Italy
Ospedale di Legnago
Legnago, Verona, Italy
Ospedale di San Bonifacio
San Bonifacio, Verona, Italy
Family Health Centre
Bassano, Vicenza, Italy
Ospedale San Bassiano
Bassano, Vicenza, Italy
General Practice
Dueville, Vicenza, Italy
General Practice
Malo, Vicenza, Italy
General Practice
Schio, Vicenza, Italy
General Practice
Sovizzo, Vicenza, Italy
Ospedale Boldrini
Thiene, Vicenza, Italy
Ospedale di Valdagno
Valdagno, Vicenza, Italy
Ospedale di Vicenza
Vicenza, VI, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Family Health Centre
Padua, , Italy
Family Health Centre
Verona, , Italy
General Practice
Verona, , Italy
Ospedale Civile Maggiore
Verona, , Italy
General Practice
Verona, , Italy
Family Health Centre
Verona, , Italy
Policlinico G.B. Rossi
Verona, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Badovinac RL, Werler MM, Williams PL, Kelsey KT, Hayes C. Folic acid-containing supplement consumption during pregnancy and risk for oral clefts: a meta-analysis. Birth Defects Res A Clin Mol Teratol. 2007 Jan;79(1):8-15. doi: 10.1002/bdra.20315.
Berry RJ, Li Z, Erickson JD, Li S, Moore CA, Wang H, Mulinare J, Zhao P, Wong LY, Gindler J, Hong SX, Correa A. Prevention of neural-tube defects with folic acid in China. China-U.S. Collaborative Project for Neural Tube Defect Prevention. N Engl J Med. 1999 Nov 11;341(20):1485-90. doi: 10.1056/NEJM199911113412001.
Botto LD, Olney RS, Erickson JD. Vitamin supplements and the risk for congenital anomalies other than neural tube defects. Am J Med Genet C Semin Med Genet. 2004 Feb 15;125C(1):12-21. doi: 10.1002/ajmg.c.30004.
Catov JM, Bodnar LM, Ness RB, Markovic N, Roberts JM. Association of periconceptional multivitamin use and risk of preterm or small-for-gestational-age births. Am J Epidemiol. 2007 Aug 1;166(3):296-303. doi: 10.1093/aje/kwm071. Epub 2007 May 11.
Czeizel AE, Dudas I. Prevention of the first occurrence of neural-tube defects by periconceptional vitamin supplementation. N Engl J Med. 1992 Dec 24;327(26):1832-5. doi: 10.1056/NEJM199212243272602.
Ingrid Goh Y, Bollano E, Einarson TR, Koren G. Prenatal multivitamin supplementation and rates of congenital anomalies: a meta-analysis. J Obstet Gynaecol Can. 2006 Aug;28(8):680-689. doi: 10.1016/S1701-2163(16)32227-7.
Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. MRC Vitamin Study Research Group. Lancet. 1991 Jul 20;338(8760):131-7.
Bortolus R, Blom F, Filippini F, van Poppel MN, Leoncini E, de Smit DJ, Benetollo PP, Cornel MC, de Walle HE, Mastroiacovo P; Italian and Dutch folic acid trial study groups. Prevention of congenital malformations and other adverse pregnancy outcomes with 4.0 mg of folic acid: community-based randomized clinical trial in Italy and the Netherlands. BMC Pregnancy Childbirth. 2014 May 13;14:166. doi: 10.1186/1471-2393-14-166.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-004334-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FARM 6KWTCT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.