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Baseline characteristics of study participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial

Baseline characteristics of study participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial
Baseline characteristics of study participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial

Recurrent enteric infections and micronutrient deficiencies, including deficiencies in the tryptophan-kynurenine-niacin pathway, have been associated with environmental enteric dysfunction, potentially contributing to poor child growth and development. We are conducting a randomized, placebo-controlled, 2 × 2 factorial interventional trial in a rural population in Haydom, Tanzania, to determine the effect of 1) antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer, on attained length at 18 months. Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020. Here, we describe the baseline characteristics of the study cohort, risk factors for low enrollment weight, and neonatal adverse events (AEs). Risk factors for a low enrollment weight included being a firstborn child (-0.54 difference in weight-for-age z-score [WAZ] versus other children, 95% CI: -0.71, -0.37), lower socioeconomic status (-0.28, 95% CI: -0.43, -0.12 difference in WAZ), and birth during the preharvest season (November to March) (-0.22, 95% CI: -0.33, -0.11 difference in WAZ). The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively). The study cohort represents a high-risk population for whom interventions to improve child growth and development are urgently needed. Further analyses are needed to understand the persistent impacts of seasonal malnutrition and the interactions between seasonality, socioeconomic status, and the study interventions.

0002-9637
1397-1404
Parpia, Tarina C.
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Elwood, Sarah E.
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Scharf, Rebecca J.
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McDermid, Joann M.
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Wanjuhi, Anne W.
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Rogawski McQuade, Elizabeth T.
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Gratz, Jean
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Svensen, Erling
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Swann, Jonathan R.
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Donowitz, Jeffrey R.
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Jatosh, Samwel
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Katengu, Siphael
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Mdoe, Paschal
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Kivuyo, Sokoine
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Houpt, Eric R.
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DeBoer, Mark D.
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Mduma, Estomih
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Platts-Mills, James A.
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Parpia, Tarina C.
80d01598-fec7-4532-9c4e-db2b73e1d340
Elwood, Sarah E.
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Scharf, Rebecca J.
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McDermid, Joann M.
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Wanjuhi, Anne W.
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Rogawski McQuade, Elizabeth T.
8c99dcd8-1acd-4021-b65e-92463c20d9bd
Gratz, Jean
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Svensen, Erling
c62db8f4-cf1b-4f69-b3ca-ef33ce19b8b7
Swann, Jonathan R.
7c11a66b-f4b8-4dbf-aa17-ad8b0561b85c
Donowitz, Jeffrey R.
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Jatosh, Samwel
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Katengu, Siphael
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Mdoe, Paschal
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Kivuyo, Sokoine
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Houpt, Eric R.
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DeBoer, Mark D.
8ca3c619-1ce0-4343-b3cd-9974d8459a3d
Mduma, Estomih
dd4035a4-cc0c-41cf-8dc6-5e1aa489e81f
Platts-Mills, James A.
52776d02-b7d3-4e89-a50a-7cbf2c1044b6

Parpia, Tarina C., Elwood, Sarah E., Scharf, Rebecca J., McDermid, Joann M., Wanjuhi, Anne W., Rogawski McQuade, Elizabeth T., Gratz, Jean, Svensen, Erling, Swann, Jonathan R., Donowitz, Jeffrey R., Jatosh, Samwel, Katengu, Siphael, Mdoe, Paschal, Kivuyo, Sokoine, Houpt, Eric R., DeBoer, Mark D., Mduma, Estomih and Platts-Mills, James A. (2020) Baseline characteristics of study participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial. American Journal of Tropical Medicine and Hygiene, 103 (4), 1397-1404. (doi:10.4269/ajtmh.19-0918).

Record type: Article

Abstract

Recurrent enteric infections and micronutrient deficiencies, including deficiencies in the tryptophan-kynurenine-niacin pathway, have been associated with environmental enteric dysfunction, potentially contributing to poor child growth and development. We are conducting a randomized, placebo-controlled, 2 × 2 factorial interventional trial in a rural population in Haydom, Tanzania, to determine the effect of 1) antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer, on attained length at 18 months. Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020. Here, we describe the baseline characteristics of the study cohort, risk factors for low enrollment weight, and neonatal adverse events (AEs). Risk factors for a low enrollment weight included being a firstborn child (-0.54 difference in weight-for-age z-score [WAZ] versus other children, 95% CI: -0.71, -0.37), lower socioeconomic status (-0.28, 95% CI: -0.43, -0.12 difference in WAZ), and birth during the preharvest season (November to March) (-0.22, 95% CI: -0.33, -0.11 difference in WAZ). The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively). The study cohort represents a high-risk population for whom interventions to improve child growth and development are urgently needed. Further analyses are needed to understand the persistent impacts of seasonal malnutrition and the interactions between seasonality, socioeconomic status, and the study interventions.

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Accepted/In Press date: 21 June 2020
e-pub ahead of print date: 10 August 2020
Published date: October 2020
Additional Information: Funding Information: Financial support: This work is supported by the Bill & Melinda Gates Foundation, OPP1141342 to E. M.; NIH 5T32AI007046-43 to T. C. P.; DDCF CSDA 2014113 to R. J. S. Publisher Copyright: Copyright © 2020 by The American Society of Tropical Medicine and Hygiene

Identifiers

Local EPrints ID: 443725
URI: http://eprints.soton.ac.uk/id/eprint/443725
ISSN: 0002-9637
PURE UUID: a08df51c-c588-4302-8348-4e9713c53067
ORCID for Jonathan R. Swann: ORCID iD orcid.org/0000-0002-6485-4529

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Date deposited: 09 Sep 2020 16:35
Last modified: 17 Mar 2024 04:00

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Contributors

Author: Tarina C. Parpia
Author: Sarah E. Elwood
Author: Rebecca J. Scharf
Author: Joann M. McDermid
Author: Anne W. Wanjuhi
Author: Elizabeth T. Rogawski McQuade
Author: Jean Gratz
Author: Erling Svensen
Author: Jeffrey R. Donowitz
Author: Samwel Jatosh
Author: Siphael Katengu
Author: Paschal Mdoe
Author: Sokoine Kivuyo
Author: Eric R. Houpt
Author: Mark D. DeBoer
Author: Estomih Mduma
Author: James A. Platts-Mills

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