Evidence map›Paper›PMID 31206083›Full record

ArticleBMJ paediatrics open2019

Effect of dose reduction of supplemental zinc for childhood diarrhoea: study protocol for a double-masked, randomised controlled trial in India and Tanzania.

Sarah S Somji, Pratibha Dhingra, Usha Dhingra, Arup Dutta, Prabhabati Devi, Jitendra Kumar, Saikat Deb, Om Prakash Semwal, Sunil Sazawal, Karim Manji and 9 more

Erratum issued Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in BMJ paediatrics open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03078842 (Establishing the Optimal Dose of Therapeutic Zinc Supplementation for the Treatment of Acute Diarrhea in Under Five Children - a Dose Response Trial in a South Asian and a Sub-Saharan African Setting), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 26% 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.

NCT03078842 nacompletednot on this map

Establishing the Optimal Dose of Therapeutic Zinc Supplementation for the Treatment of Acute Diarrhea in Under Five Children - a Dose Response Trial in a South Asian and a Sub-Saharan African Setting

TypeinterventionalSponsorAyesha De CostaRan2017 to 2020Enrolled4,500ConditionsDiarrheaArmsZinc tablets, 20 mg per day, Zinc tablets, 10 mg per day, Zinc tablets, 5 mg per day
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 6 institutions in 5 countries.

Sarah S SomjiDepartment of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania.
Pratibha DhingraCentre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.
Usha DhingraCentre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.
Arup DuttaCentre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.
Prabhabati DeviCentre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.
Jitendra KumarCentre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.
Saikat DebCentre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.
Om Prakash SemwalCentre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.
Sunil SazawalCentre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.
Karim ManjiDepartment of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania.
Rodrick KisengeDepartment of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania.
Mohamed BakariDepartment of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania.
Said AboudDepartment of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania.
Enju LiuBoston Children's Hospital, Boston, MA.
Christopher SudfeldHarvard University T H Chan School of Public Health, Boston, Massachusetts, USA.
Christopher P DugganDivision of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, MA.
Per AshornTampereen yliopisto, Tampere, Finland.
Rajiv BahlOrganisation mondiale de la Sante, Geneva, Switzerland.
Jonathon L SimonOrganisation mondiale de la Sante, Geneva, Switzerland.ORCID 0000-0001-6740-549X
The Centre for Health (New Zealand) · NZMuhimbili University of Health and Allied Sciences · TZBoston Children's Hospital · USWorld Health Organization · CHHarvard University · USTampere University · FI

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI CHRISTOPHER P DUGGAN · 1994 to 2026
$31.6M
Patient-oriented Research in Pediatric Diarrheal DiseasesK24DK104676 · NIDDK · BOSTON CHILDREN'S HOSPITAL · PI DUGGAN, CHRISTOPHER P · 2015 to 2019
$903k
NCATS NIH HHS UL1 TR001102NIDDK NIH HHS K24 DK104676NIDDK NIH HHS P30 DK040561
6 · The paper itself

Abstract

backgroundDiarrhoea-associated mortality and morbidity are highest in infants and young children in low-income and middle-income countries (LMICs). Zinc supplementation during acute diarrhoea has been shown to reduce the duration of illness and the risk of persistent diarrhoea. However, vomiting with zinc supplementation is a common side effect that may interfere with compliance and programmatic scale-up, and may be related to the dose prescribed. METHODS/

designThe Zinc Therapeutic Dose Trial (ZTDT) is a two-centre (Tanzania and India), three-arm randomised, double-blind controlled non-inferiority trial. Children 6-59 months of age with acute diarrhoea are eligible to participate. Enrolled children (1500 per arm; 4500 total) will be randomly allocated to receive 5, 10 or 20 mg of zinc sulfate daily for 14 days and will be followed up for 60 days after enrolment. All children will receive WHO/Unicef Integrated Management of Childhood Illness standard of care (oral or intravenous rehydration and zinc as indicated and feeding advice). The primary efficacy outcomes of the trial are the percentage of subjects with diarrhoea duration >5 days, the mean total number of loose or watery stools after enrolment and the proportion of children vomiting within 30 min of zinc administration. DISCUSSION: The ZTDT trial will determine the optimal dose of therapeutic zinc supplements for treatment of acute diarrhoea in children aged 6-59 months in two LMICs. The results of the trial are likely to be generalisable to childhood acute diarrhoea in similar resource-limited settings and may influence global policy about zinc supplementation dosage during acute diarrhoea. TRIAL REGISTRATION NUMBER: NCT03078842. TRIAL STATUS: Enrolment began in January 2017 and follow-up is estimated to be completed by April 2019. As of 1 February 2019, 742 children are still contributing data to the ZTDT study.

Indexed as

general paediatricspaediatric practicepharmacologytropical inf dis

Identifiers

PMID31206083
PMCPMC6542451
OpenAlexW2941355461

What OpenQuestion holds

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LicenceCC BY
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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.