[2630.7] Vitamin D Supplementation during Pregnancy Part I NICHD/CTSA Randomized Clinical Trial (RCT): Safety Considerations

Carol L. Wagner, Donna Johnson, Thomas C. Hulsey, Myla Ebeling, Judy Shary, Pamela G. Smith, Betty Bivens, Bruce W. Hollis. Pediatrics, Medical University of SC, Charleston, SC.

BACKGROUND: Vitamin D (vitD) deficiency during pregnancy is a serious public health issue that affects both mother and fetus. Establishing the optimal vitD requirements of the pregnant woman is vital in preventing vitD deficiency.
OBJECTIVE: Evaluate the safety of high dose vitD supplementation during pregnancy in a RCT.
DESIGN/METHODS: Following their consent, pregnant women 12-16 wks' gestation were randomized into 1 of 3 treatment (tx) groups (grps) stratified by race: 400, 2000 or 4000 IU vitD₃/day until delivery. Women were evaluated for safety, efficacy and effectiveness with monthly 25(OH)D; 1,25(OH)₂D; serum Ca, Cr, phos, and urinary Ca/Cr levels, all measured using standardized methodology. Investigators & health team were blinded to tx grp.
RESULTS: Of the 494 women who enrolled in the study, 350 women continued until delivery: 98 African American, 137 Hispanic and 115 Caucasian women; with 111 controls, 122 in 2000 IU and 117 in 4000 IU grps. There were no differences in baseline 25(OH)D by dose grp. The mean 25(OH)D by dose grp at delivery, as chronic level, and 1-month before delivery were significantly different between control and 2000, control and 4000, and 2000 vs. 4000 (p<0.0001). 25(OH)D had a direct influence on 1,25(OH)₂D levels throughout pregnancy (p<0.0001). Throughout the study, there were no differences between grps on any safety measure: serum Ca, Cr, urinary Ca/Cr ratios (pNS between grps). Not a single adverse event was attributed to vitD supplementation by the DSMB. Neonatal 25(OH)D was significantly correlated with maternal 25(OH)D overall, 1-month prior and at delivery (r²=0.6; OR 0.50); and was significantly different by tx group: 18.2±10.1 (control), 22.8±9.8 (2000 IU) and 26.5±10.3 ng/mL (4000 IU), (p<0.0001).


CONCLUSIONS: VitD supplementation of 4,000 IU vitD/day for pregnant women was safe and effective in achieving vitD sufficiency. We recommend this daily regimen for all pregnant women.
E-PAS20102630.7

Date: Sunday, May 2, 2010
Platform Session: CTSA Supported Pediatric Clinical Translational Research (1:00 PM - 3:00 PM)
Presentation Time: 2:30 PM
Room: 220 - Vancouver Convention Centre
Course Number: 2630