Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201809756724274 Date of Approval: 03/09/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Randomised, Double-Blind, Placebo-Controlled Trial of the Effects of Selenium Supplementation on Pregnancy Outcome and Disease Progression in HIV-Infected Pregnant Women in Lagos, Nigeria
Official scientific title A Randomised, Double-Blind, Placebo-Controlled Trial of the Effects of Selenium Supplementation on Pregnancy Outcome and Disease Progression in HIV-Infected Pregnant Women in Lagos, Nigeria
Brief summary describing the background and objectives of the 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. Aims: This study is aimed at assessing the effect of selenium supplementation on major pregnancy outcomes and disease progression among HIV-infected pregnant women in Lagos, Nigeria. Methods: This is a randomized, double-blind, placebo-controlled trial involving confirmed HIV-positive pregnant women at the Lagos University Teaching Hospital between August 2018 and January 2019. Eligible participants are HIV-infected pregnant women aged 15 to 49 years and have a singleton gestation at 14 to 26 weeks’ gestation. At enrolment, participants will be randomly assigned in equal numbers until the end of the enrolment period to receive a daily tablet of 200μg elemental selenium or placebo. Data on the participants’ characteristics will be collected at enrolment and at delivery. Statistical Analysis Plan: Statistical analyses will be carried out using SPSS version 22.0 for Windows. The associations between any two groups of continuous variables will be tested using the independent sample t-test or the Mann-Whitney U test and that of two groups of categorical variables with chi-square or Fisher's 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<0.05.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/08/2018
Actual trial start date 02/09/2019
Anticipated date of last follow up 12/04/2019
Actual Last follow-up date 30/09/2019
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Selenium 200μg Till delivery The active intervention is a daily oral tablet of 200μg elemental selenium (arm I) or placebo (arm II) till their delivery The active intervention drug and placebo tablets will be indistinguishable in shape, size, and colour and will be packed in identical coded transparent dispensing sachets. 90
Control Group Placebo Nil Till delivery The control drug is a daily oral tablet of placebo (arm II). The active intervention drug and placebo tablets will be indistinguishable in shape, size, and colour and will be packed in identical coded transparent dispensing sachets. 90 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant women aged 15 to 49 years 2. Singleton gestation at 14 to 26 weeks’ gestation 3. On antiretroviral treatment (ART) for at least 3 months prior to enrolment. 1. Multiple Gestations 2. Significant renal and hepatic impairment 3. An expected delivery date beyond March 2019 4. Mid-trimester pregnancy loss in the index pregnancy 5. Receipt of a long course of a mineral supplement containing selenium during the 6 months prior to enrolment 6. Refusal of consent at enrolment or withdrawal of consent during the study 7. Failure to receive the study intervention (selenium or placebo) for a cumulative period of at least 8 weeks before delivery. 8. To be excluded in the final analysis of the primary end-points (see below) are women who delivered by Caesarean section or those who had iatrogenic preterm delivery. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/08/2018 Lagos University Teaching Hospitals Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room 107, Administrative block Lagos 2345 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Preterm delivery At delivery
Primary Outcome Low birth weight in term neonates. At delivery
Secondary Outcome HIV disease progression (Change in CD4+ cells count, viral load and stage of the disease) At delivery
Secondary Outcome Change in Haemoglobin levels At delivery
Secondary Outcome Adverse events (AE) At delivery
Secondary Outcome Perinatal mortality. In pregnancy, delivery and at one week of life
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital PMB 12003 Lagos 2345 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health 10 Center Dr, Bethesda Maryland 20814 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor College of Medicine University of Lagos PMB 12003 Lagos Nigeria University
Secondary Sponsor Lagos University Teaching hospital PMB 12003 Lagos 2345 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Department of Hematology and Blood Transfusion PMB 12003 Lagos 2345 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kehinde Okunade sokunade@unilag.edu.ng +2348034728139 Department of Obstetrics and Gynaecology College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos 2345 Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Kehinde Okunade sokunade@unilag.edu.ng +2348034728139 Department of Obstetrics and Gynaecology College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos 2345 Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Kehinde Okunade sokunade@unilag.edu.ng +2348034728139 Department of Obstetrics and Gynaecology College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos 2345 Nigeria Levcturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All deidentified participants data Clinical Study Report,Statistical Analysis Plan,Study Protocol July 2019 to June 2021 None at this moment
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information