Evidence map›Paper›PMID 30653086›Full record

ArticleMedicine2019

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.

Kehinde S Okunade, Sarah John-Olabode, Oluwatosin J Akinsola, Opeyemi Akinajo, Sulaimon A Akanmu, Phyllis J Kanki

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Effects of selenium supplementation on pregnancy outcomes and disease progression in HIV-infected pregnant women in Lagos: A randomized controlled trial.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2021
    Trial
  2. Article
  3. Oxidative Stress in Pregnancy.Biomolecules · 2023
    Review
  4. Placental transcriptomic signatures of spontaneous preterm birth.American journal of obstetrics and gynecology · 2023
    Article
  5. Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Kehinde S OkunadeDepartment of Obstetrics & Gynaecology.
Sarah John-OlabodeDepartment of Haematology & Blood Transfusion.
Oluwatosin J AkinsolaEpidemiology and Biostatistics unit, Department of Community Health & Primary Health Care, College of Medicine, University of Lagos.
Opeyemi AkinajoDepartment of Obstetrics & Gynaecology, Lagos University Teaching Hospital, Nigeria.
Sulaimon A AkanmuDepartment of Haematology & Blood Transfusion.
Phyllis J KankiDepartment of Immunology & Infectious Diseases, Harvard School of Public Health, USA.
Lagos University Teaching Hospital · NGUniversity of Lagos · NG

Funding

Partnership for Global Health Research Training Program (Renewal)-Supplement for OBSSR, NCI, NCI-AIDS and NIDCDD43TW010543 · FIC · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Wafaie W Fawzi, DAVIDSON HOWES HAMER · 2017 to 2026
$12.1M
FIC NIH HHS D43 TW010543
6 · The paper itself

Abstract

backgroundMicronutrient 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.

methodsA 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 registrationPACTR, PACTR201809756724274. Registered on 3rd September 2018, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3571.

Indexed as

AdolescentAdultCD4 Lymphocyte CountDisease ProgressionDouble-Blind MethodFemaleHIV-1HIV InfectionsHumansMiddle AgedNigeriaPlacebosPregnancyPregnancy Complications, InfectiousPregnancy OutcomeProspective StudiesPlacebosSeleniumTrace Elements

Identifiers

PMID30653086
PMCPMC6370178
OpenAlexW2909736240

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.