Effects of selenium supplementation on pregnancy outcome and disease progression in HIV-infected pregnant women in Lagos, Nigeria: Study protocol for a randomised, double-blind, placebo-controlled trial

Background: Micronutrient deficiencies are common during pregnancy, especially in pregnant women from economically disadvantaged settings where diets with low content of minerals and vitamins are consumed. Selenium is a non-metallic chemical element of great importance to human health. This study will assess the effect of selenium supplementation on major pregnancy outcomes and disease progression among HIV-infected pregnant women in Lagos, Nigeria. Methods: A randomized, double-blind, placebo-controlled trial involving confirmed HIV-positive pregnant women at the Lagos University Teaching Hospital (LUTH) between September 2018 and February 2019. Eligible participants are HIV-infected pregnant women aged 15 to 49 years and have a singleton gestation at 14 to 27 weeks’ gestation. At enrolment, 90 women will be randomly assigned into each intervention arm to receive either a daily tablet of 200 μg elemental selenium or placebo. Relevant participants’ data will be collected at enrolment and at delivery. Statistical analyses will be carried out using SPSS version 23.0 for Windows. The associations between any 2 groups of continuous variables will be tested using the t test or the Mann-Whitney U test and that of 2 groups of categorical variables with chi-square or Fishers exact test where appropriate. A series of multivariable analyses will also be carried out to identify and control for several possible confounders of the major pregnancy outcomes and HIV disease progression. Statistical significance will be defined as P < .05. Ethical approval for the study was obtained from the LUTH's Health Research and Ethics Committee (Approval number: ADM/DCST/HREC/APP/2438; 30th August 2018). Discussion: This trial will assess the effect of selenium supplementation on pregnancy outcome and HIV disease progression among HIV-infected pregnant women in Lagos. This will help to determine if routine selenium supplementation in HIV-infected pregnant women will contribute to the improvement in the major adverse pregnancy outcomes such as preterm birth and low birth weight and the HIV disease surrogate markers such as CD4+ cells count and viral load. Trial registration: PACTR, PACTR201809756724274. Registered on 3rd September 2018, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3571

Effects of selenium supplementation on pregnancy outcomes and disease progression in HIV-infected pregnant women in Lagos: A randomized controlled trial

Objective To examine the effects of selenium supplementation on pregnancy outcomes and disease progression among HIV-infected pregnant women in Lagos. Methods A randomized, placebo-controlled trial conducted among HIV-positive pregnant women between September 2018 and August 2019. At enrollment, 90 women were randomly assigned into each treatment arm to receive either a daily tablet of 200 μg elemental selenium or a placebo. Relevant participants' sociodemographic and clinical data were collected at enrollment and delivery. Results Women in the selenium arm had a significantly lower risk of preterm delivery (relative risk [RR] 0.32, 95% confidence interval [CI] 0.11–0.96) and a non-significant reduction in the risk of delivering term neonates with a low delivery weight (RR 0.24, 95% CI 0.05–1.19). Supplemental selenium does not increase the risk of perinatal death and adverse drug events. Conclusion The study reported a beneficial effect of prenatal selenium supplements on the risk of preterm delivery with no further reduction in risk among HIV-infected women who used the supplements for more than 14 weeks. Trial registration Pan African Clinical Trial Registry (PACTR201809756724274)