Hungarian Prenatal Vitamin Trial
Trial question
Is periconceptional supplementation of vitamins superior to trace-element supplements in females planning a pregnancy?
Study design
Multi-center
Open label
RCT
Population
4156 female patients.
Inclusion criteria: females 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
13.3%
22.9%
22.9 %
17.2 %
11.4 %
5.7 %
0.0 %
Vitamin
supplementation
Trace-element
supplementation
Significant
decrease ▼
NNT = 10
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 (0 vs. 6; 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 females 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.
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