Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Nov 14;9(11):e027548.
doi: 10.1136/bmjopen-2018-027548.

TAME trial: a multi-arm phase II randomised trial of four novel interventions for malnutrition enteropathy in Zambia and Zimbabwe - a study protocol

Paul Kelly  1   2   3 , Lauren Bell  3 , Beatrice Amadi  2 , Mutsa Bwakura-Dangarembizi  4   5 , Kelley VanBuskirk  2 , Kanta Chandwe  2 , Miyoba Chipunza  2 , Deophine Ngosa  2 , Nivea Chulu  2 , Susan Hill  6 , Simon Murch  7 , Raymond Playford  8 , Andrew Prendergast  8   5
Affiliations

TAME trial: a multi-arm phase II randomised trial of four novel interventions for malnutrition enteropathy in Zambia and Zimbabwe - a study protocol

Paul Kelly et al. BMJ Open. .

Abstract

Introduction: Severe acute malnutrition (SAM) in children in many countries still carries unacceptably high mortality, especially when complicated by secondary infection or metabolic derangements. New therapies are urgently needed and we have identified mucosal healing in the intestine as a potential target for novel treatment approaches.

Methods and analysis: The TAME trial (Therapeutic Approaches for Malnutrition Enteropathy) will evaluate four novel treatments in an efficient multi-arm single-blind phase II design. In three hospitals in Zambia and Zimbabwe, 225 children with SAM will be randomised to one of these treatments or to standard care, once their inpatient treatment has reached the point of transition from stabilisation to increased nutritional intake. The four interventions are budesonide, bovine colostrum or N-acetyl glucosamine given orally or via nasogastric tube, or teduglutide given by subcutaneous injection. The primary endpoint will be a composite score of faecal inflammatory markers, and a range of secondary endpoints include clinical and laboratory endpoints. Treatments will be given daily for 14 days, and evaluation of the major endpoints will be at 14 to 18 days, with a final clinical evaluation at 28 days. In a subset of children in Zambia, endoscopic biopsies will be used to evaluate the effect of interventions in detail.

Ethics and dissemination: The study has been approved by the University of Zambia Biomedical Research Ethics Committee (006-09-17, dated 9th July, 2018), and the Joint Research Ethics Committee of the University of Zimbabwe (24th July, 2019). Caregivers will provide written informed consent for each participant. Findings will be disseminated through peer-reviewed journals, conference presentations and to caregivers at face-to-face meetings.

Trial registration number: NCT03716115; Pre-results.

Keywords: clinical trials; nutrition & dietetics; paediatric gastroenterology; tropical medicine.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flowchart of recruitment into the TAME trial. GlcNAc,N-acetyl glucosamine; TAME, Therapeutic Approaches for Malnutrition Enteropathy.
See this image and copyright information in PMC

References

    1. Black RE, Victora CG, Walker SP, et al. . Maternal and child undernutrition and overweight in low-income and middle-income countries. The Lancet 2013;382:427–51. 10.1016/S0140-6736(13)60937-X - DOI - PubMed
    1. ICF Zambia demographic and health survey 2013-14; Zimbabwe demographic and health survey. Rockville, Maryland, USA: Central Statistical Office, Ministry of Health, and ICF International, 2015.
    1. Olofin I, McDonald CM, Ezzati M, et al. . Associations of suboptimal growth with all-cause and cause-specific mortality in children under five years: a pooled analysis of ten prospective studies. PLoS One 2013;8:e64636 10.1371/journal.pone.0064636 - DOI - PMC - PubMed
    1. Victora CG, Adair L, Fall C, et al. . Maternal and child undernutrition: consequences for adult health and human capital. The Lancet 2008;371:340–57. 10.1016/S0140-6736(07)61692-4 - DOI - PMC - PubMed
    1. Lenters LM, Wazny K, Webb P, et al. . Treatment of severe and moderate acute malnutrition in low- and middle-income settings: a systematic review, meta-analysis and Delphi process. BMC Public Health 2013;13:S23 10.1186/1471-2458-13-S3-S23 - DOI - PMC - PubMed

Publication types

MeSH terms

Associated data

LinkOut - more resources