The effects of vitamin C supplementation on pre-eclampsia in Mulago Hospital, Kampala, Uganda: a randomized placebo controlled clinical trial

BACKGROUND: Oxidative stress plays a role in the pathogenesis of pre-eclampsia. Supplementing women with antioxidants during pregnancy may reduce oxidative stress and thereby prevent or delay the onset pre-eclampsia. The objective of this study was to evaluate the effect of supplementing vitamin C in pregnancy on the incidence of pre-eclampsia, at Mulago hospital, Kampala, Uganda. METHODS: This was a (parallel, balanced randomization, 1:1) placebo randomized controlled trial conducted at Mulago hospital, Department of Obstetrics and Gynecology. Participants included in this study were pregnant women aged 15-42 years, who lived 15 km or less from the hospital with gestational ages between 12-22 weeks. The women were randomized to take 1000mg of vitamin C (as ascorbic acid) or a placebo daily until they delivered. The primary outcome was pre-eclamsia. Secondary outcomes were: severe pre-eclampsia, gestational hypertension, preterm delivery, low birth weight and still birth delivery. Participants were 932 pregnant women randomized into one of the two treatment arms in a ratio of 1:1. The participants, the care providers and those assessing the outcomes were blinded to the study allocation. RESULTS: Of the 932 women recruited; 466 were randomized to the vitamin and 466 to the placebo group. Recruitment of participants was from November 2011 to June 2012 and follow up was up to January 2013. Outcome data was available 415 women in the vitamin group and 418 women in the placebo group. There were no differences in vitamin and placebo groups in the incidence of pre-eclampsia (3.1% versus 4.1%; RR 0.77; 95% CI: 0.37-1.56), severe pre-eclampsia (1.2% versus 1.0%; RR 1.25; 95% CI: 0.34-4.65), gestational hypertension(7.7% versus 11.5%; RR 0.67; 95% CI: 0.43-1.03), preterm delivery (11.3% versus 12.2%; RR 0.92; 95% CI: 0.63-1.34), low birth weight (11.1% versus 10.3%; RR 1.07; 95% CI: 0.72-1.59) and still birth delivery (4.6% versus 4.5%; RR 1.01; 95% CI: 0.54-1.87). CONCLUSIONS: Supplementation with vitamin C did not reduce the incidence of pre-eclampsia nor did it reduce the adverse maternal or neonatal outcomes. We do not recommend the use of vitamin C in pregnancy to prevent pre-eclampsia. TRIAL REGISTRATION: This study was registered at the Pan African Clinical Trial Registry, PACTR201210000418271 on 25(th) October 2012.