Iron-fortified Lentils to Improve Iron (Fe) Status in Bangladesh

Summary

We designed a double-blind, community-based, cluster-randomized control trial which will test to establish novel evidence on the efficacy of iron-fortified lentil in improving body Fe status of non-pregnant adolescents in rural Mymensingh district of Bangladesh. Lentils will be fortified with iron in the lab setting at the Crop Development Center (CDC) of the University of Saskatchewan in Canada. There will be three lentils based dietary intervention arm in this efficacy trial. Arm 1 will be intervened with iron-fortified lentils, Arm 2 will be non-iron fortified lentils, and Arm 3 arm will be the usual intake of lentil (no additional lentil). Arm 2 will be served as a comparison group and arm 3 will be served as control group. A total of 420 adolescent girls (including 20% drop-outs) - aged 10 - 17y; non-smoking, not pregnant, not breastfeeding, and generally healthy will be included in each arm - a total of 1260 adolescent girls in all three arms. Participating adolescents will be served thick preparation of cooked lentils (37.5gm raw lentil) 5 days a week for 85 feeding days (around 4+months). Socio-demographic characteristics, household food security status, and adolescent food habits will be collected at baseline and endline data point. Furthermore, venous blood will be collected to measure adolescents' Fe status at baseline, midline, and endline for 85 feeding days (5 days a week)- approx. 4+ months. In addition, Ravens Progressive Matrices will be used for non-verbal measurement of the cognitive ability of advanced observation and thinking skills specific to capacity for analyzing and solving problems, abstract reasoning, and the ability to learn of the adolescents. Both descriptive and inferential statistics will be used for this study. Serum ferritin level and cognitive performance is the primary outcome. The trial expects that the supplemental Fe from the iron-fortified lentils will improve body Fe status and cognitive performance after controlling for baseline Fe status and dietary Fe intake in this group of adolescent girls. The secondary outcome is the participants' anthropometries. Considering the amount of plant protein from lentils that need to be consumed to for the study, it is expected to have significant improvement in growth of the participants which will lead to increased productivity.

Conditions

• Anemia, Iron-Deficiency
• Cognitive Performance
• Iron-deficiency

Interventions

DIETARY_SUPPLEMENT

Iron fortified lentils

Lentils will be iron-fortified using NaFeEDTA iron fortificants

OTHER

Non Iron-fortified lentils

Non-fortified lentils will be provided

OTHER

Usual Intake

No lentils will be provided.

Sponsors & Collaborators

• Brac

  collaborator OTHER

• Marywood University

  collaborator OTHER

• Nutrition International

  collaborator OTHER

• Carol Henry

  lead OTHER

Principal Investigators

• Albert Vandenberg, PhD · University of Saskatchewan

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

17 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-09-30

Primary Completion

2019-04-09

Completion

2021-04-30

Countries

• Bangladesh

Study Locations