Evidence map›Paper›PMID 31349866›Full record

ArticleTrials2019

Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia.

Dibyadyuti Datta, Ruth Namazzi, Andrea L Conroy, Sarah E Cusick, Heather A Hume, Abner Tagoola, Russell E Ware, Robert O Opoka, Chandy C John

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03528434 (for Infection Prevention in Sickle Cell Anemia), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 27% 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.

NCT03528434 nacompletednot on this map

for Infection Prevention in Sickle Cell Anemia (ZIPS)

TypeinterventionalSponsorIndiana UniversityRan2019 to 2020Enrolled250ConditionsSickle Cell DiseaseArmsZinc, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Antioxidant supplementation for sickle cell disease.The Cochrane database of systematic reviews · 2024
    Pooled it
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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

9 authors at 6 institutions in 3 countries.

Dibyadyuti DattaRyan White Center for Pediatric Infectious Disease and Global Health, Department of Pediatrics, Indiana University School of Medicine, 1044 W. Walnut St, R4 402D, Indianapolis, IN, 46202, USA.
Ruth NamazziDepartment of Paediatrics and Child Health, Makerere University, Kampala, Uganda.
Andrea L ConroyRyan White Center for Pediatric Infectious Disease and Global Health, Department of Pediatrics, Indiana University School of Medicine, 1044 W. Walnut St, R4 402D, Indianapolis, IN, 46202, USA.
Sarah E CusickDepartment of Pediatrics, University of Minnesota School of Medicine, Minneapolis, MN, USA.
Heather A HumeUniversity of Montreal, Montreal, Canada.
Abner TagoolaJinja Regional Referral Hospital, Jinja, Uganda.
Russell E WareCincinnati Children's Hospital, Cincinnati, Ohio, USA.
Robert O OpokaDepartment of Paediatrics and Child Health, Makerere University, Kampala, Uganda.
Chandy C JohnRyan White Center for Pediatric Infectious Disease and Global Health, Department of Pediatrics, Indiana University School of Medicine, 1044 W. Walnut St, R4 402D, Indianapolis, IN, 46202, USA. chjohn@iu.edu.ORCID http://orcid.org/0000-0002-1634-1411
Indiana University School of MedicineMakerere University · UGCincinnati Children's Hospital Medical Center · USJinja Hospital · UGUniversité de Montréal · CAUniversity of Minnesota · US

Funding

Research training in infection, nutrition and neurodevelopment in UgandaD43TW010928 · FIC · INDIANA UNIVERSITY INDIANAPOLIS · PI Chandy C. John · 2018 to 2026
$1.9M
FIC NIH HHS D43 TW010928Thrasher Research Fund 14221
6 · The paper itself

Abstract

backgroundSickle 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/

designThe 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 registrationClinicaltrials.gov, NCT03528434. Registered on May 17, 2018 Protocol Version: 1.0. Date: Dec 11, 2017 Sponsor: Indiana University. Sponsor's protocol identifier, 1712339562.

Indexed as

Dietary SupplementsAnemia, Sickle CellBacterial InfectionsChild, PreschoolDouble-Blind MethodFemaleHumansInfantMaleRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeUgandaZinc SulfateZinc SulfateSickle cell anemiaUgandaZinc

Identifiers

PMID31349866
PMCPMC6660664
OpenAlexW2965072776

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.