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Ensayo controlado aleatorizado2013

A randomized trial of vitamin D supplementation in 2 community health center networks in South Carolina

Wagner CL, McNeil R, Hamilton SA, Winkler J, Rodriguez Cook C, Warner G, Bivens B, Davis DJ, Smith PG, Murphy M, Shary JR, Hollis BW

American journal of obstetrics and gynecology · 114 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento

Quién lo pagó

Financiación
Financiación independiente
Gobierno
National Center for Research Resources
Gobierno
NCRR NIH HHS
Subvenciones
National Center for Research Resources (#UL1RR029882); National Center for Research Resources (RR-01070); National Center for Research Resources (M01 RR001070)

Según 2 financiadores declarados.

Publicación

Publicado
2012-11-03 · Am J Obstet Gynecol · vol. 208 · número 2 · págs. 137.e1–137.e13
Editorial
Elsevier BV
Citado
190 citas · más que el 99% de estudios similares · 12.1× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
93 trabajos
Acceso
Acceso abierto (copia en repositorio)
Áreas de investigación
Vitamin D Research Studies · Vitamin K Research Studies · Nutrition and Health Studies
Palabras clave
vitamin D supplementation, pregnancy, 25-hydroxyvitamin D, dose-response relationship, hypercalciuria, hypercalcemia, cord blood vitamin D, preterm birth, preterm labor, maternal vitamin D status, neonatal vitamin D status
MeSH
fetal blood, humans, calcium, vitamins, vitamin d, pregnancy outcome, double-blind method, pregnancy, dose-response relationship, drug, maternal welfare, dietary supplements, adult, community health centers, south carolina, female, young adult, surveys and questionnaires

12 autores

  • Carol L. Wagner🇺🇸 · autor de correspondenciaMedical University of South Carolina
  • Rebecca B. McNeil🇺🇸Durham VA Medical Center
  • Stuart A. Hamilton
  • Joyce Winkler
  • Carolina Rodriguez Cook
  • Gloria Warner
  • Betty Bivens🇺🇸Medical University of South Carolina
  • Deborah J. Davis
  • Pamela G. Smith🇺🇸Medical University of South Carolina
  • Martha Murphy🇺🇸Medical University of South Carolina
  • Judy R. Shary🇺🇸Medical University of South Carolina
  • Bruce W. Hollis🇺🇸Medical University of South Carolina

Resumen

El texto original del estudio, en el idioma en que se publicó.

Objective

We sought to determine whether 4000 IU/d (vs 2000 IU/d) of vitamin D during pregnancy is safe and improves maternal/neonatal 25-hydroxyvitamin D [25(OH)D] in a dose-dependent manner.

Study design

A total of 257 pregnant women 12-16 weeks' gestation were enrolled. Randomization to 2000 vs 4000 IU/d followed 1-month run-in at 2000 IU/d. Participants were monitored for hypercalciuria, hypercalcemia, and 25(OH)D status.

Results

Maternal 25(OH)D (n = 161) increased from 22.7 ng/mL (SD 9.7) at baseline to 36.2 ng/mL (SD 15) and 37.9 ng/mL (SD 13.5) in the 2000 and 4000 IU groups, respectively. While maternal 25(OH)D change from baseline did not differ between groups, 25(OH)D monthly increase differed between groups (P < .01). No supplementation-related adverse events occurred. Mean cord blood 25(OH)D was 22.1 ± 10.3 ng/mL in 2000 IU and 27.0 ± 13.3 ng/mL in 4000 IU groups (P = .024). After controlling for race and study site, preterm birth and labor were inversely associated with predelivery and mean 25(OH)D, but not baseline 25(OH)D.

Conclusion

Maternal supplementation with vitamin D 2000 and 4000 IU/d during pregnancy improved maternal/neonatal vitamin D status. Evidence of risk reduction in infection, preterm labor, and preterm birth was suggestive, requiring additional studies powered for these endpoints.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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