6/28/23, 11:10 PM Hungarian Prenatal Vitamin Trial Pathway Feedback Search Clinical Topics Home Studies Hungarian Prenatal Vitamin Trial Hungarian Prenatal Vitamin Trial Disease Disease Myelomeningocele Vitamins, minerals, and dietary s Trial question Is periconceptional supplementation of vitamins superior to trace-element supplement in women planning a pregnancy? Study design Multi-center Open label RCT Population 4156 female patients Inclusion criteria: women planning a pregnancy Key exclusion criteria: delayed conception or infertility, currently pregnant, age of > 35 years, and a history of previous unwanted pregnancy Interventions N=2104 vitamin supplementation (a single tablet containing 12 vitamins, including 0.8 mg of folic acid; 4 minerals; and 3 trace elements daily for at least one month before conception and until the date of the second missed menstrual period or later) N=2052 trace-element supplementation (a single tablet containing copper, manganese, zinc, and a very low dose of vitamin C daily for at least one month before conception and until the date of the second missed menstrual period or later) Primary outcome Congenital malformations 22.9 % 22.9 17.2 % 13.3 11.4 % Significant decrease 5.7 % https://web.pathway.md/studies/recfc8MyqFCDMmi5A 1/2 6/28/23, 11:10 PM Hungarian Prenatal Vitamin Trial Pathway NNT = 10 0.0 % Vitamin supplementation Trace-element supplementation Significant decrease in congenital malformations (13.3% vs. 22.9%; RR 0.58, 95% CI 0.09 to 1.07) Secondary outcomes Significant decrease in neural-tube defects (ARD -6, 95% CI -11.39 to -0.61) Safety outcomes No significant difference in prevalence of cleft lip with or without cleft palate (4 vs. 3). Conclusion In women planning a pregnancy, vitamin supplementation was superior to trace-element supplementation with respect to congenital malformations. Reference 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. Open reference URL https://web.pathway.md/studies/recfc8MyqFCDMmi5A 2/2