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

• Published in: Medicine (Baltimore) 2019-01, Vol.98 (3), p.e12735-e12735
• Main Authors: Okunade, Kehinde S., John-Olabode, Sarah, Akinsola, Oluwatosin J., Akinajo, Opeyemi, Akanmu, Sulaimon A., Kanki, Phyllis J.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; CD4 Lymphocyte Count - methods; Disease Progression; Double-Blind Method; Female; HIV Infections - drug therapy; HIV Infections - metabolism; HIV-1 - drug effects; Humans; Middle Aged; Nigeria - epidemiology; Placebos; Pregnancy; Pregnancy Complications, Infectious - drug therapy; Pregnancy Complications, Infectious - epidemiology; Pregnancy Complications, Infectious - virology; Pregnancy Outcome - epidemiology; Prospective Studies; Selenium - administration & dosage; Selenium - therapeutic use; Study Protocol Clinical Trial; Trace Elements - administration & dosage; Trace Elements - therapeutic use; Viral Load - drug effects; Viral Load - methods; Young Adult
• ISSN: 0025-7974; 1536-5964
• DOI: 10.1097/MD.0000000000012735

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. 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