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Randomized Controlled Trial
. 2013 Feb;208(2):137.e1-13.
doi: 10.1016/j.ajog.2012.10.888. Epub 2012 Nov 3.

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

Carol L Wagner  1 , Rebecca McNeil, Stuart A Hamilton, Joyce Winkler, Carolina Rodriguez Cook, Gloria Warner, Betty Bivens, Deborah J Davis, Pamela G Smith, Martha Murphy, Judy R Shary, Bruce W Hollis
Affiliations
Randomized Controlled Trial

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

Carol L Wagner et al. Am J Obstet Gynecol. 2013 Feb.

Abstract

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.

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Figures

Figure 1
Figure 1
CONSORT Flow Diagram for this randomized clinical trial.
Figure 2
Figure 2. A and B: Percent of Infants by Treatment Group Plotted by Fenton Growth Curve Percentiles for Weight (A) and Head Circumference (B)
The percent of children within each treatment group who were at the 3rd, 10th, 50th, 90th, and 97th percentiles for weight (A) and head circumference (B). Less than the 10th percentile is defined as small-for-gestational age (SGA); 10–90th percentile as appropriate-for-gestational age (AGA); and >90th percentile as large-for-gestational age (LGA).
Figure 3
Figure 3
Longitudinal serum calcium (mg/dL) with group overlay by treatment group, with each participant’s serum calcium values plotted over time.
Figure 4
Figure 4
Longitudinal urinary calcium: creatinine ratios (mg/dL/mg/dL) with group overlay by treatment group, with each participant’s urinary calcium: creatinine ratios plotted over time.
Figure 5
Figure 5
Longitudinal total circulating 25(OH)D (ng/mL) with group overlay by treatment
See this image and copyright information in PMC

References

    1. Vieth R, Bischoff-Ferrari H, Boucher B, Dawson-Hughes B, Garland C, Heaney R, et al. The urgent need to recommend an intake of vitamin D that is effective. Am J Clin Nutr. 2007;85:649–50. - PubMed
    1. Hamilton S, McNeil R, Hollis B, Davis D, Winkler J, Cook C, et al. Profound Vitamin D deficiency in a diverse group of women during pregnancy living in a sun-rich environment at latitude 32°N. International J Endocrinol. 2010 doi: 10.1155/2010/917428. - DOI - PMC - PubMed
    1. Johnson DD, Wagner CL, Hulsey TC, McNeil RB, Ebeling M, Hollis BW. Vitamin D Deficiency and Insufficiency is Common during Pregnancy. Am J Perinatol. 2011;28(1):7–12. doi: 10.1055/s-0030-1262505. Epub 2010/07/20. - DOI - PubMed
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    1. Hamilton SA, McNeil R, Hollis BW, Davis DJ, Winkler J, Cook C, et al. Profound Vitamin D Deficiency in a Diverse Group of Women during Pregnancy Living in a Sun-Rich Environment at Latitude 32 degrees N. Int J Endocrinol. 2010;2010:917428. doi: 10.1155/2010/917428. Epub 2011/01/05. - DOI - PMC - PubMed

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