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

Phase 3

• Conditions: HIV/AIDS; Pregnancy and Childbirth

• Registration Number: PACTR201809756724274
• Lead Sponsor: College of Medicine University of Lagos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified