Background: The use of antioxidants during pregnancy has not been shown to reduce pre-eclampsia in several trials, but the effect on women with diabetes is unknown. We planned to survey whether supplementation with nutrients C and E diminished frequency of toxemia in ladies with type 1 diabetes.
Methods: In a multicenter, randomized, placebo-controlled study, we recruited women from 25 UK antenatal metabolic clinics. Type 1 diabetes prior to pregnancy, presentation between 8 and 22 weeks of gestation, a singleton pregnancy, and age 16 or older were the eligibility criteria. Up until the time of delivery, women were assigned at random in a 1:1 ratio to receive either a matched placebo or 1000 mg of vitamin C and 400 IU of vitamin E (-tocopherol). Eight balanced blocks of patients comprised the stratified center of the randomization sequence. The treatment allocation was hidden from both trial personnel and participants. The essential endpoint was toxemia, which we characterized as gestational hypertension with proteinuria. Examination was by changed aim to treat. The ISRCTN number for this study is ISRCTN27214045.
Results: Between April, 2003, and June, 2008, 762 ladies were haphazardly apportioned to treatment gatherings (379 nutrient supplementation, 383 fake treatment). The primary endpoint was evaluated for 375 women who were given vitamins and 374 women who were given a placebo. Preeclampsia rates were the same in the vitamin (15 percent, n=57) and placebo (19 percent, 70) groups (risk ratio 0–81, 95% CI 0–59–112). There were no reports of adverse maternal or neonatal outcomes.
Conclusion: Supplementation with nutrients C and E didn't lessen hazard of toxemia in ladies with type 1 diabetes. However, additional research is needed to determine whether vitamin supplementation might be beneficial to women with low antioxidant status at baseline.
