Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection – a double blind, randomised controlled trial in Burkina Faso
Abstract Background Provision of routine iron supplements to prevent anaemia could increase the risk for lower genital tract infections as virulence of some pathogens depends on iron availability. This trial in Burkina Faso assessed whether weekly periconceptional iron supplementation increased the...
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2017-11-01
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Online Access: | http://link.springer.com/article/10.1186/s12916-017-0967-5 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Loretta Brabin Stephen A. Roberts Sabine Gies Andrew Nelson Salou Diallo Christopher J. Stewart Adama Kazienga Julia Birtles Sayouba Ouedraogo Yves Claeys Halidou Tinto Umberto d’Alessandro E. Brian Faragher Bernard Brabin |
spellingShingle |
Loretta Brabin Stephen A. Roberts Sabine Gies Andrew Nelson Salou Diallo Christopher J. Stewart Adama Kazienga Julia Birtles Sayouba Ouedraogo Yves Claeys Halidou Tinto Umberto d’Alessandro E. Brian Faragher Bernard Brabin Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection – a double blind, randomised controlled trial in Burkina Faso BMC Medicine Lower genital tract infection Iron Antibiotics Adolescents Burkina Faso |
author_facet |
Loretta Brabin Stephen A. Roberts Sabine Gies Andrew Nelson Salou Diallo Christopher J. Stewart Adama Kazienga Julia Birtles Sayouba Ouedraogo Yves Claeys Halidou Tinto Umberto d’Alessandro E. Brian Faragher Bernard Brabin |
author_sort |
Loretta Brabin |
title |
Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection – a double blind, randomised controlled trial in Burkina Faso |
title_short |
Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection – a double blind, randomised controlled trial in Burkina Faso |
title_full |
Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection – a double blind, randomised controlled trial in Burkina Faso |
title_fullStr |
Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection – a double blind, randomised controlled trial in Burkina Faso |
title_full_unstemmed |
Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection – a double blind, randomised controlled trial in Burkina Faso |
title_sort |
effects of long-term weekly iron and folic acid supplementation on lower genital tract infection – a double blind, randomised controlled trial in burkina faso |
publisher |
BMC |
series |
BMC Medicine |
issn |
1741-7015 |
publishDate |
2017-11-01 |
description |
Abstract Background Provision of routine iron supplements to prevent anaemia could increase the risk for lower genital tract infections as virulence of some pathogens depends on iron availability. This trial in Burkina Faso assessed whether weekly periconceptional iron supplementation increased the risk of lower genital tract infection in young non-pregnant and pregnant women. Methods Genital tract infections were assessed within a double blind, controlled, non-inferiority trial of malaria risk among nulliparous women, randomised to receive either iron and folic acid or folic acid alone, weekly, under direct observation for 18 months. Women conceiving during this period entered the pregnancy cohort. End assessment (FIN) for women remaining non-pregnant was at 18 months. For the pregnancy cohort, end assessment was at the first scheduled antenatal visit (ANC1). Infection markers included Nugent scores for abnormal flora and bacterial vaginosis (BV), T. vaginalis PCR, vaginal microbiota, reported signs and symptoms, and antibiotic and anti-fungal prescriptions. Iron biomarkers were assessed at baseline, FIN and ANC1. Analysis compared outcomes by intention to treat and in iron replete/deficient categories. Results A total of 1954 women (mean 16.8 years) were followed and 478 (24.5%) became pregnant. Median supplement adherence was 79% (IQR 59–90%). Baseline BV prevalence was 12.3%. At FIN and ANC1 prevalence was 12.8% and 7.0%, respectively (P < 0.011). T. vaginalis prevalence was 4.9% at FIN and 12.9% at ANC1 (P < 0.001). BV and T. vaginalis prevalence and microbiota profiles did not differ at trial end-points. Iron-supplemented non-pregnant women received more antibiotic treatments for non-genital infections (P = 0.014; mainly gastrointestinal infections (P = 0.005), anti-fungal treatments for genital infections (P = 0.014) and analgesics (P = 0.008). Weekly iron did not significantly reduce iron deficiency prevalence. At baseline, iron-deficient women were more likely to have normal vaginal flora (P = 0.016). Conclusions Periconceptional weekly iron supplementation of young women did not increase the risk of lower genital tract infections but did increase general morbidity in the non-pregnant cohort. Unabsorbed gut iron due to malaria could induce enteric infections, accounting for the increased administration of antibiotics and antifungals in the iron-supplemented arm. This finding reinforces concerns about routine iron supplementation in highly malarious areas. Trial registration Trial registration number NCT01210040 . Registered with Clinicaltrials.gov on 27 September 2010 |
topic |
Lower genital tract infection Iron Antibiotics Adolescents Burkina Faso |
url |
http://link.springer.com/article/10.1186/s12916-017-0967-5 |
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doaj-a95e65330f3943aeb07d09aef92c82382020-11-25T00:55:51ZengBMCBMC Medicine1741-70152017-11-0115111310.1186/s12916-017-0967-5Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection – a double blind, randomised controlled trial in Burkina FasoLoretta Brabin0Stephen A. Roberts1Sabine Gies2Andrew Nelson3Salou Diallo4Christopher J. Stewart5Adama Kazienga6Julia Birtles7Sayouba Ouedraogo8Yves Claeys9Halidou Tinto10Umberto d’Alessandro11E. Brian Faragher12Bernard Brabin13Division of Cancer Sciences, Faculty of Biology, Medicine and Health, School of Medical Sciences, University of Manchester, Manchester Academic Health Science CentreCentre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, Faculty of Biology, Medicine and Health, School of Medical Sciences, University of Manchester, Manchester Academic Health Science CentreDepartment of Biomedical Sciences, Prince Leopold Institute of Tropical MedicineFaculty of Health and Life Sciences, Northumberland Building, University of NorthumbriaClinical Research Unit, Institute for Research in Health Sciences, (IRSS-URCN)Molecular Virology and Microbiology, Baylor College of MedicineClinical Research Unit, Institute for Research in Health Sciences, (IRSS-URCN)Central Manchester University Hospitals NHS Foundation Trust, Microbiology DepartmentClinical Research Unit, Institute for Research in Health Sciences, (IRSS-URCN)Clinical Trials Unit, Prince Leopold Institute of Tropical MedicineMedical Research Council Unit (MRC)Clinical Research Unit, Institute for Research in Health Sciences, (IRSS-URCN)Clinical Division, Liverpool School of Tropical MedicineLiverpool School of Tropical Medicine and Institute of Infection and Global Health, University of LiverpoolAbstract Background Provision of routine iron supplements to prevent anaemia could increase the risk for lower genital tract infections as virulence of some pathogens depends on iron availability. This trial in Burkina Faso assessed whether weekly periconceptional iron supplementation increased the risk of lower genital tract infection in young non-pregnant and pregnant women. Methods Genital tract infections were assessed within a double blind, controlled, non-inferiority trial of malaria risk among nulliparous women, randomised to receive either iron and folic acid or folic acid alone, weekly, under direct observation for 18 months. Women conceiving during this period entered the pregnancy cohort. End assessment (FIN) for women remaining non-pregnant was at 18 months. For the pregnancy cohort, end assessment was at the first scheduled antenatal visit (ANC1). Infection markers included Nugent scores for abnormal flora and bacterial vaginosis (BV), T. vaginalis PCR, vaginal microbiota, reported signs and symptoms, and antibiotic and anti-fungal prescriptions. Iron biomarkers were assessed at baseline, FIN and ANC1. Analysis compared outcomes by intention to treat and in iron replete/deficient categories. Results A total of 1954 women (mean 16.8 years) were followed and 478 (24.5%) became pregnant. Median supplement adherence was 79% (IQR 59–90%). Baseline BV prevalence was 12.3%. At FIN and ANC1 prevalence was 12.8% and 7.0%, respectively (P < 0.011). T. vaginalis prevalence was 4.9% at FIN and 12.9% at ANC1 (P < 0.001). BV and T. vaginalis prevalence and microbiota profiles did not differ at trial end-points. Iron-supplemented non-pregnant women received more antibiotic treatments for non-genital infections (P = 0.014; mainly gastrointestinal infections (P = 0.005), anti-fungal treatments for genital infections (P = 0.014) and analgesics (P = 0.008). Weekly iron did not significantly reduce iron deficiency prevalence. At baseline, iron-deficient women were more likely to have normal vaginal flora (P = 0.016). Conclusions Periconceptional weekly iron supplementation of young women did not increase the risk of lower genital tract infections but did increase general morbidity in the non-pregnant cohort. Unabsorbed gut iron due to malaria could induce enteric infections, accounting for the increased administration of antibiotics and antifungals in the iron-supplemented arm. This finding reinforces concerns about routine iron supplementation in highly malarious areas. Trial registration Trial registration number NCT01210040 . Registered with Clinicaltrials.gov on 27 September 2010http://link.springer.com/article/10.1186/s12916-017-0967-5Lower genital tract infectionIronAntibioticsAdolescentsBurkina Faso |