NCT03516734

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

February 28, 2018

Last Update Submit

November 2, 2020

Conditions

Anemia, Iron-DeficiencyCognitive PerformanceIron-deficiency

Keywords

Iron deficiencyFood-based dietary intervention

Outcome Measures

Primary Outcomes (1)

  • Changes in Serum ferritin level (micrograms per liter)

    Body Fe status (micrograms per liter) will be measured at baseline, midline, and endline at 85 feeding days (5 days a week)- approx. 4+ months

    85 feeding days

Secondary Outcomes (9)

  • Cognitive performance [(non-verbal measurement), # items correct out of 60-item test]

    85 feeding days (change from baseline cognitive ability at endpoint)

  • Attention assessment (# of correct response)

    85 feeding days (change from baseline attention at endpoint)

  • Visual memory assessment [Time (seconds and milliseconds)]

    85 feeding days (change from baseline visual memory at endpoint)

  • Height (centimetre)

    85 feeding days

  • Body weight (kilogram)

    85 feeding days

  • +4 more secondary outcomes

Study Arms (3)

Iron fortified lentils

EXPERIMENTAL

Lentils will be fortified with iron in the lab setting at the Crop Development Center (CDC) of The University of Saskatchewan, Canada. The study will fortify lentil by spraying iron fortificant NaFeEDTA solution. A small sprayer will be placed at the beginning of the lentil polishing machine at a commercial lentil mill located near Saskatoon, Canada. The iron solution will be applied as a fine mist which will be absorbed into the lentil as it travels through the polishing drum. As the fortified lentil leaves the drum it will be bagged in 20 kg food grade bags. The expected concentration of Fe in the final product will be approximately 21 mg/100 g of lentil (fortified with NaFeEDTA solution with 1600 ppm of Fe).

Dietary Supplement: Iron fortified lentils

Non iron-fortified lentils

ACTIVE COMPARATOR

It will be the same Saskatchewan (province of Canada) grown small cotyledon color lentil (Iron content 75-90ppm) without the iron fortification.

Other: Non Iron-fortified lentils

Usual Intake (no intervention)

PLACEBO COMPARATOR

It will be the usual intake of lentil- no additional lentil will be provided. However, participants will be free to consume lentils from anywhere (homemade or restaurants) if they want to, except our fortified lentils.

Other: Usual Intake

Interventions

Iron fortified lentilsDIETARY_SUPPLEMENT

Lentils will be iron-fortified using NaFeEDTA iron fortificants

Iron fortified lentils
Non Iron-fortified lentilsOTHER

Non-fortified lentils will be provided

Non iron-fortified lentils
Usual IntakeOTHER

No lentils will be provided.

Usual Intake (no intervention)

Eligibility Criteria

Age10 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on self-representation of gender identity.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescent girls who attend the BRAC adolescent clubs
  • Age between 10 -17 years
  • Non-smoking
  • Not pregnant
  • Not breastfeeding
  • Generally healthy.

You may not qualify if:

  • Unwilling to participate
  • Active illness during recruitment
  • Known case of Infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BRAC Research and Evaluation Division

Dhaka, 1212, Bangladesh

Location

Related Publications (2)

  • Yunus FM, Jalal C, Das A, Afsana K, Podder R, Vandenberg A, DellaValle DM. Consumption of Iron-Fortified Lentils Is Protective against Declining Iron Status among Adolescent Girls in Bangladesh: Evidence from a Community-Based Double-Blind, Cluster-Randomized Controlled Trial. J Nutr. 2024 May;154(5):1686-1698. doi: 10.1016/j.tjnut.2024.03.005. Epub 2024 Mar 6.

    PMID: 38458577DERIVED

  • Yunus FM, Jalal C, Afsana K, Podder R, Vandenberg A, DellaValle DM. Iron-fortified lentils to improve iron (Fe) status among adolescent girls in Bangladesh - study protocol for a double-blind community-based randomized controlled trial. Trials. 2019 May 2;20(1):251. doi: 10.1186/s13063-019-3309-4.

    PMID: 31046819DERIVED

MeSH Terms

Conditions

Anemia, Iron-DeficiencyIron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Albert Vandenberg, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Participants, care provider, and investigators will be masked on the distribution of iron-fortified lentil among 3 different adolescent group.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Thick preparation of cooked Iron-fortified lentils (37.5gm raw lentil) will be provided. 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2018

First Posted

May 4, 2018

Study Start

September 30, 2018

Primary Completion

April 9, 2019

Study Completion

April 30, 2021

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

BA(1)