High vitamin A intake in early pregnancy and major malformations: A multicenter prospective controlled study

P. Mastroiacovo, T. Mazzone, A. Addis, E. Elephant, P. Carlier, T. Vial, H. Garbis, E. Robert, M. Bonati, A. Ornoy, A. Finardi, C. Schaffer, L. Caramelli, E. Rodríguez-Pinilla, M. Clementi

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

The European Network of the Teratology Information Services (ENTIS) collected and evaluated data on 423 pregnancies exposed during the first 9 weeks of gestation to a 'high' dose of vitamin A (10,000 IU per day or more). Data were collected prospectively; 394 women (93.1%) were followed by telephone interview up to the first few weeks after the expected date of delivery, using standardized procedures. The presence of major structural malformations, excluding chromosomal and genetic diseases, was evaluated in 311 infants exposed to a median daily dose of vitamin A of 50,000 IU per day (range, 10,000-300,000 IU per day; interquartile range, 25,000-60,000 IU per day). Three infants with a major malformation were reported: pulmonary stenosis, stenotic anus with fistula, and bilateral inguinal hernia. No congenital malformations were reported among 120 infants exposed to more than 50,000 IU per day of vitamin A. When the birth prevalence rate of major malformations in the study group was compared with two internal control groups of infants exposed to: 1) 'high' vitamin A exposure later in pregnancy, and 2) nonteratogenic agent exposures, the rate ratio was, respectively, 0.28 (CI 95% interval, 0.06, 1.23) and 0.50 (CI 95% interval, 0.14, 1.76). The studied sample did not provide evidence for an increased risk of major malformations, associated with 'high' vitamin A intake during the organogenetic period, higher than 2.76 above the control reference risk of 1.91% (power 80%, alpha 0.10).

Original languageEnglish
Pages (from-to)7-11
Number of pages5
JournalTeratology
Volume59
Issue number1
DOIs
Publication statusPublished - 1999

Fingerprint

Vitamin A
Prospective Studies
Pregnancy
Teratology
Inborn Genetic Diseases
Pulmonary Valve Stenosis
Information Services
Inguinal Hernia
Birth Rate
Anal Canal
Information services
Telephone
Fistula
Interviews
Control Groups

ASJC Scopus subject areas

  • Developmental Biology
  • Embryology
  • Toxicology
  • Health, Toxicology and Mutagenesis

Cite this

High vitamin A intake in early pregnancy and major malformations : A multicenter prospective controlled study. / Mastroiacovo, P.; Mazzone, T.; Addis, A.; Elephant, E.; Carlier, P.; Vial, T.; Garbis, H.; Robert, E.; Bonati, M.; Ornoy, A.; Finardi, A.; Schaffer, C.; Caramelli, L.; Rodríguez-Pinilla, E.; Clementi, M.

In: Teratology, Vol. 59, No. 1, 1999, p. 7-11.

Research output: Contribution to journalArticle

Mastroiacovo, P, Mazzone, T, Addis, A, Elephant, E, Carlier, P, Vial, T, Garbis, H, Robert, E, Bonati, M, Ornoy, A, Finardi, A, Schaffer, C, Caramelli, L, Rodríguez-Pinilla, E & Clementi, M 1999, 'High vitamin A intake in early pregnancy and major malformations: A multicenter prospective controlled study', Teratology, vol. 59, no. 1, pp. 7-11. https://doi.org/10.1002/(SICI)1096-9926(199901)59:1<7::AID-TERA4>3.0.CO;2-6
Mastroiacovo, P. ; Mazzone, T. ; Addis, A. ; Elephant, E. ; Carlier, P. ; Vial, T. ; Garbis, H. ; Robert, E. ; Bonati, M. ; Ornoy, A. ; Finardi, A. ; Schaffer, C. ; Caramelli, L. ; Rodríguez-Pinilla, E. ; Clementi, M. / High vitamin A intake in early pregnancy and major malformations : A multicenter prospective controlled study. In: Teratology. 1999 ; Vol. 59, No. 1. pp. 7-11.
@article{41df48166e1b4111a7955f64a40c404d,
title = "High vitamin A intake in early pregnancy and major malformations: A multicenter prospective controlled study",
abstract = "The European Network of the Teratology Information Services (ENTIS) collected and evaluated data on 423 pregnancies exposed during the first 9 weeks of gestation to a 'high' dose of vitamin A (10,000 IU per day or more). Data were collected prospectively; 394 women (93.1{\%}) were followed by telephone interview up to the first few weeks after the expected date of delivery, using standardized procedures. The presence of major structural malformations, excluding chromosomal and genetic diseases, was evaluated in 311 infants exposed to a median daily dose of vitamin A of 50,000 IU per day (range, 10,000-300,000 IU per day; interquartile range, 25,000-60,000 IU per day). Three infants with a major malformation were reported: pulmonary stenosis, stenotic anus with fistula, and bilateral inguinal hernia. No congenital malformations were reported among 120 infants exposed to more than 50,000 IU per day of vitamin A. When the birth prevalence rate of major malformations in the study group was compared with two internal control groups of infants exposed to: 1) 'high' vitamin A exposure later in pregnancy, and 2) nonteratogenic agent exposures, the rate ratio was, respectively, 0.28 (CI 95{\%} interval, 0.06, 1.23) and 0.50 (CI 95{\%} interval, 0.14, 1.76). The studied sample did not provide evidence for an increased risk of major malformations, associated with 'high' vitamin A intake during the organogenetic period, higher than 2.76 above the control reference risk of 1.91{\%} (power 80{\%}, alpha 0.10).",
author = "P. Mastroiacovo and T. Mazzone and A. Addis and E. Elephant and P. Carlier and T. Vial and H. Garbis and E. Robert and M. Bonati and A. Ornoy and A. Finardi and C. Schaffer and L. Caramelli and E. Rodr{\'i}guez-Pinilla and M. Clementi",
year = "1999",
doi = "10.1002/(SICI)1096-9926(199901)59:1<7::AID-TERA4>3.0.CO;2-6",
language = "English",
volume = "59",
pages = "7--11",
journal = "Teratology",
issn = "0040-3709",
publisher = "John Wiley and Sons Inc.",
number = "1",

}

TY - JOUR

T1 - High vitamin A intake in early pregnancy and major malformations

T2 - A multicenter prospective controlled study

AU - Mastroiacovo, P.

AU - Mazzone, T.

AU - Addis, A.

AU - Elephant, E.

AU - Carlier, P.

AU - Vial, T.

AU - Garbis, H.

AU - Robert, E.

AU - Bonati, M.

AU - Ornoy, A.

AU - Finardi, A.

AU - Schaffer, C.

AU - Caramelli, L.

AU - Rodríguez-Pinilla, E.

AU - Clementi, M.

PY - 1999

Y1 - 1999

N2 - The European Network of the Teratology Information Services (ENTIS) collected and evaluated data on 423 pregnancies exposed during the first 9 weeks of gestation to a 'high' dose of vitamin A (10,000 IU per day or more). Data were collected prospectively; 394 women (93.1%) were followed by telephone interview up to the first few weeks after the expected date of delivery, using standardized procedures. The presence of major structural malformations, excluding chromosomal and genetic diseases, was evaluated in 311 infants exposed to a median daily dose of vitamin A of 50,000 IU per day (range, 10,000-300,000 IU per day; interquartile range, 25,000-60,000 IU per day). Three infants with a major malformation were reported: pulmonary stenosis, stenotic anus with fistula, and bilateral inguinal hernia. No congenital malformations were reported among 120 infants exposed to more than 50,000 IU per day of vitamin A. When the birth prevalence rate of major malformations in the study group was compared with two internal control groups of infants exposed to: 1) 'high' vitamin A exposure later in pregnancy, and 2) nonteratogenic agent exposures, the rate ratio was, respectively, 0.28 (CI 95% interval, 0.06, 1.23) and 0.50 (CI 95% interval, 0.14, 1.76). The studied sample did not provide evidence for an increased risk of major malformations, associated with 'high' vitamin A intake during the organogenetic period, higher than 2.76 above the control reference risk of 1.91% (power 80%, alpha 0.10).

AB - The European Network of the Teratology Information Services (ENTIS) collected and evaluated data on 423 pregnancies exposed during the first 9 weeks of gestation to a 'high' dose of vitamin A (10,000 IU per day or more). Data were collected prospectively; 394 women (93.1%) were followed by telephone interview up to the first few weeks after the expected date of delivery, using standardized procedures. The presence of major structural malformations, excluding chromosomal and genetic diseases, was evaluated in 311 infants exposed to a median daily dose of vitamin A of 50,000 IU per day (range, 10,000-300,000 IU per day; interquartile range, 25,000-60,000 IU per day). Three infants with a major malformation were reported: pulmonary stenosis, stenotic anus with fistula, and bilateral inguinal hernia. No congenital malformations were reported among 120 infants exposed to more than 50,000 IU per day of vitamin A. When the birth prevalence rate of major malformations in the study group was compared with two internal control groups of infants exposed to: 1) 'high' vitamin A exposure later in pregnancy, and 2) nonteratogenic agent exposures, the rate ratio was, respectively, 0.28 (CI 95% interval, 0.06, 1.23) and 0.50 (CI 95% interval, 0.14, 1.76). The studied sample did not provide evidence for an increased risk of major malformations, associated with 'high' vitamin A intake during the organogenetic period, higher than 2.76 above the control reference risk of 1.91% (power 80%, alpha 0.10).

UR - http://www.scopus.com/inward/record.url?scp=0033031677&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0033031677&partnerID=8YFLogxK

U2 - 10.1002/(SICI)1096-9926(199901)59:1<7::AID-TERA4>3.0.CO;2-6

DO - 10.1002/(SICI)1096-9926(199901)59:1<7::AID-TERA4>3.0.CO;2-6

M3 - Article

C2 - 9988877

AN - SCOPUS:0033031677

VL - 59

SP - 7

EP - 11

JO - Teratology

JF - Teratology

SN - 0040-3709

IS - 1

ER -