Cargando…
Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia
BACKGROUND: Sickle cell anemia (SCA) is the most common inherited hemoglobinopathy worldwide. Infection is a major cause of illness and death in children with SCA, especially in sub-Saharan Africa where an estimated 50–90% of affected children die before their fifth birthday. Interventions to reduce...
Autores principales: | , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6660664/ https://www.ncbi.nlm.nih.gov/pubmed/31349866 http://dx.doi.org/10.1186/s13063-019-3569-z |
_version_ | 1783439344390897664 |
---|---|
author | Datta, Dibyadyuti Namazzi, Ruth Conroy, Andrea L. Cusick, Sarah E. Hume, Heather A. Tagoola, Abner Ware, Russell E. Opoka, Robert O. John, Chandy C. |
author_facet | Datta, Dibyadyuti Namazzi, Ruth Conroy, Andrea L. Cusick, Sarah E. Hume, Heather A. Tagoola, Abner Ware, Russell E. Opoka, Robert O. John, Chandy C. |
author_sort | Datta, Dibyadyuti |
collection | PubMed |
description | BACKGROUND: Sickle cell anemia (SCA) is the most common inherited hemoglobinopathy worldwide. Infection is a major cause of illness and death in children with SCA, especially in sub-Saharan Africa where an estimated 50–90% of affected children die before their fifth birthday. Interventions to reduce the incidence and severity of infections are needed urgently. A high proportion of adults and children with SCA are zinc-deficient, and zinc deficiency leads to impaired immunity and an increased risk of infection. Zinc supplementation has been shown to decrease the risk of infection in adolescents and adults, but there are no data on the effectiveness of zinc for prevention of infection in children < 5 years of age with SCA. METHODS/DESIGN: The study will be a randomized, placebo-controlled, double-blind clinical trial in which 250 Ugandan children 1.00–4.99 years of age with SCA will receive daily zinc supplementation (10 mg oral dispersible tablet) or identical placebo for 12 months. DISCUSSION: If this trial shows a reduction in severe or invasive infection incidence, it would be the basis for a multi-site, multi-country clinical trial to assess real-world safety and efficacy of zinc in African children with SCA. Since zinc is safe, inexpensive, and easy to administer, this trial has the potential to improve the health of hundreds of thousands of African children with SCA through reduction of infection-related morbidity and mortality. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03528434. Registered on May 17, 2018 Protocol Version: 1.0. Date: Dec 11, 2017 Sponsor: Indiana University. Sponsor’s protocol identifier, 1712339562 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3569-z) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6660664 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-66606642019-08-01 Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia Datta, Dibyadyuti Namazzi, Ruth Conroy, Andrea L. Cusick, Sarah E. Hume, Heather A. Tagoola, Abner Ware, Russell E. Opoka, Robert O. John, Chandy C. Trials Study Protocol BACKGROUND: Sickle cell anemia (SCA) is the most common inherited hemoglobinopathy worldwide. Infection is a major cause of illness and death in children with SCA, especially in sub-Saharan Africa where an estimated 50–90% of affected children die before their fifth birthday. Interventions to reduce the incidence and severity of infections are needed urgently. A high proportion of adults and children with SCA are zinc-deficient, and zinc deficiency leads to impaired immunity and an increased risk of infection. Zinc supplementation has been shown to decrease the risk of infection in adolescents and adults, but there are no data on the effectiveness of zinc for prevention of infection in children < 5 years of age with SCA. METHODS/DESIGN: The study will be a randomized, placebo-controlled, double-blind clinical trial in which 250 Ugandan children 1.00–4.99 years of age with SCA will receive daily zinc supplementation (10 mg oral dispersible tablet) or identical placebo for 12 months. DISCUSSION: If this trial shows a reduction in severe or invasive infection incidence, it would be the basis for a multi-site, multi-country clinical trial to assess real-world safety and efficacy of zinc in African children with SCA. Since zinc is safe, inexpensive, and easy to administer, this trial has the potential to improve the health of hundreds of thousands of African children with SCA through reduction of infection-related morbidity and mortality. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03528434. Registered on May 17, 2018 Protocol Version: 1.0. Date: Dec 11, 2017 Sponsor: Indiana University. Sponsor’s protocol identifier, 1712339562 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3569-z) contains supplementary material, which is available to authorized users. BioMed Central 2019-07-26 /pmc/articles/PMC6660664/ /pubmed/31349866 http://dx.doi.org/10.1186/s13063-019-3569-z Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Datta, Dibyadyuti Namazzi, Ruth Conroy, Andrea L. Cusick, Sarah E. Hume, Heather A. Tagoola, Abner Ware, Russell E. Opoka, Robert O. John, Chandy C. Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia |
title | Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia |
title_full | Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia |
title_fullStr | Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia |
title_full_unstemmed | Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia |
title_short | Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia |
title_sort | zinc for infection prevention in sickle cell anemia (zips): study protocol for a randomized placebo-controlled trial in ugandan children with sickle cell anemia |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6660664/ https://www.ncbi.nlm.nih.gov/pubmed/31349866 http://dx.doi.org/10.1186/s13063-019-3569-z |
work_keys_str_mv | AT dattadibyadyuti zincforinfectionpreventioninsicklecellanemiazipsstudyprotocolforarandomizedplacebocontrolledtrialinugandanchildrenwithsicklecellanemia AT namazziruth zincforinfectionpreventioninsicklecellanemiazipsstudyprotocolforarandomizedplacebocontrolledtrialinugandanchildrenwithsicklecellanemia AT conroyandreal zincforinfectionpreventioninsicklecellanemiazipsstudyprotocolforarandomizedplacebocontrolledtrialinugandanchildrenwithsicklecellanemia AT cusicksarahe zincforinfectionpreventioninsicklecellanemiazipsstudyprotocolforarandomizedplacebocontrolledtrialinugandanchildrenwithsicklecellanemia AT humeheathera zincforinfectionpreventioninsicklecellanemiazipsstudyprotocolforarandomizedplacebocontrolledtrialinugandanchildrenwithsicklecellanemia AT tagoolaabner zincforinfectionpreventioninsicklecellanemiazipsstudyprotocolforarandomizedplacebocontrolledtrialinugandanchildrenwithsicklecellanemia AT warerusselle zincforinfectionpreventioninsicklecellanemiazipsstudyprotocolforarandomizedplacebocontrolledtrialinugandanchildrenwithsicklecellanemia AT opokaroberto zincforinfectionpreventioninsicklecellanemiazipsstudyprotocolforarandomizedplacebocontrolledtrialinugandanchildrenwithsicklecellanemia AT johnchandyc zincforinfectionpreventioninsicklecellanemiazipsstudyprotocolforarandomizedplacebocontrolledtrialinugandanchildrenwithsicklecellanemia |