Randomized, placebo controlled, double blind trial evaluating early pregnancy phytonutrient supplementation in the prevention of preeclampsia.

OBJECTIVE

Daily provision of pregnant patients with dietary supplements containing antioxidants and phytonutrients, if initiated in the first trimester of pregnancy and continued throughout the gestation, may significantly decrease the incidence of preeclampsia.

STUDY DESIGN

We conducted a single center, randomized, placebo-controlled investigation in which women were randomized by their risk status and assigned to daily ingestion of a supplement consisting primarily of a blended fruit and vegetable juice powder concentrate or placebo.

RESULT

Of the 684 patients randomized to the trial, 267 (39.0%) completed it. The final analysis is based on those participants who completed the study. For the primary outcome of preeclampsia, there was no difference observed between the phytonutrient supplement group and the placebo group: 15.9% vs 16.3%, respectively, (R.R. 0.97 (0.56-1.69)). Non-significant trends toward lower placenta-related obstetrical complications were observed in the supplement group compared with the placebo cohort (8.3% vs 15.5%, respectively, (R.R. 0.57 (0.29-1.14). Those infants born to mothers taking the supplement in the high-risk stratified group demonstrated non-significant trends toward lower rates of respiratory distress syndrome (RDS); 5.3% in the supplement group vs 15.4% in the placebo group: R.R. 0.34 (0.12-1.01).

CONCLUSION

Initiation of antioxidant/phytonutrient supplementation in the first trimester did not decrease rates of preeclampsia. Non-significant trends toward lower incidences of placental derived morbidity in those mothers taking the supplement in addition to decreased rates of RDS in infants born to supplemented mothers considered to be high-risk for preeclampsia, warrant further investigation.