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Open Access 01-12-2019 | Study protocol

Iron-fortified lentils to improve iron (Fe) status among adolescent girls in Bangladesh - study protocol for a double-blind community-based randomized controlled trial

Authors: Fakir Md Yunus, Chowdhury Jalal, Kaosar Afsana, Rajib Podder, Albert Vandenberg, Diane M. DellaValle

Published in: Trials | Issue 1/2019

Abstract

Background

Lentils are generally considered to be a nutrient-dense food, and a good source of iron (Fe). This study aims to establish novel evidence of the effectiveness of the consumption of Fe-fortified lentils in improving the body Fe status and thus cognitive performance in non-pregnant adolescent girls in rural Bangladesh, compared to consumption of ordinary lentils.

Methods

We have designed a double-blind (both trial participants and outcome assessors), community-based, cluster-randomized controlled trial among 1260 Bangladeshi adolescent girls between the ages of 10–17 years who are non-smoking, not married, not pregnant, not breastfeeding, and generally healthy at the time of enrollment. The intervention will include three arms who will receive: (1) Fe-fortified lentils; (2) unfortified lentils; or (3) usual intake. Participants will be served a thick preparation of cooked Fe-fortified lentils (37.5 g raw lentils, approximately 200 g cooked lentils) 5 days per week for 85 feeding days (around 4 months) using a locally acceptable recipe. Lentils were fortified with Fe in the laboratory at the Department of Plant Sciences at the University of Saskatchewan in Canada. A subsample of participants (n = 360) will be randomly invited to be included in cognitive testing.

Discussion

Data on socio-demographic characteristics, household food security status, adolescent food habits and cognitive testing will be collected at baseline and endline (4 months). Venous blood samples will be collected at baseline, midline (2 months) and endline to measure adolescents’ Fe status. Computerized cognitive testing will include five common measures of attentional (three of attention) and mnemonic functioning (two of memory) carried out using DMDX software. The results of this study will be used to garner support for and to substantiate large-scale production and market expansion of Fe-fortified lentils, and will contribute to knowledge about how to enhance Fe status in adolescents worldwide in resource-poor settings, using staple food crops.

Trial registration

ClinicalTrials.gov NCT03516734. Registered on 24 May 2018.

Available only for authorised users

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Title: Iron-fortified lentils to improve iron (Fe) status among adolescent girls in Bangladesh - study protocol for a double-blind community-based randomized controlled trial
Authors: Fakir Md Yunus
Chowdhury Jalal
Kaosar Afsana
Rajib Podder
Albert Vandenberg
Diane M. DellaValle
Publication date: 01-12-2019
Publisher: BioMed Central
Published in: Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-019-3309-4

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Iron-fortified lentils to improve iron (Fe) status among adolescent girls in Bangladesh - study protocol for a double-blind community-based randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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