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

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ClinicalTrials.gov Identifier: NCT03516734
Recruitment Status : Not yet recruiting
First Posted : May 4, 2018
Last Update Posted : May 24, 2018
Sponsor:
Collaborators:
Brac
Marywood University
Nutrition International
Information provided by (Responsible Party):
Carol Henry, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Anemia, Iron-Deficiency Cognitive Performance Iron-deficiency Dietary Supplement: Iron fortified lentils Other: Non Iron-fortified lentils Other: Usual Intake Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Participants, care provider, and investigators will be masked on the distribution of iron-fortified lentil among 3 different adolescent group.
Primary Purpose: Other
Official Title: The Effect of Iron-fortified Lentils on the Iron (Fe) Status Among the Adolescent Girls in Bangladesh- a Double-blind Randomized Controlled Trial
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : November 15, 2018
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Iron fortified lentils
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
Lentils will be iron-fortified using NaFeEDTA iron fortificants

Active Comparator: Non iron-fortified lentils
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
Non-fortified lentils will be provided

Placebo Comparator: Usual Intake (no intervention)
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
No lentils will be provided.




Primary Outcome Measures :
  1. Changes in Serum ferritin level (micrograms per liter) [ Time Frame: 85 feeding days ]
    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


Secondary Outcome Measures :
  1. Cognitive performance [(non-verbal measurement), # items correct out of 60-item test] [ Time Frame: 85 feeding days (change from baseline cognitive ability at endpoint) ]

    Standard 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. The booklet comprises five sets (A to E) of 12 items each (e.g., A1 through A12), with items within a set becoming increasingly difficult, requiring ever greater cognitive capacity to encode and analyze information. All items are presented in black ink on a white background.

    Higher the number of correct answers higher the cognitive ability.

    It would take around 45 minutes per participant.


  2. Attention assessment (# of correct response) [ Time Frame: 85 feeding days (change from baseline attention at endpoint) ]

    Attention assessment (# of correct response) test will be administered via The Cambridge Neuropsychological Test Automated Battery (CANTAB) [www.cambridgecognition.com].

    Higher number of correct responses would be treated as better performer.

    Tests would take around 45 minutes per adolescent.


  3. Visual memory assessment [Time (seconds and milliseconds)] [ Time Frame: 85 feeding days (change from baseline visual memory at endpoint) ]

    Visual memory assessment by test administered via The Cambridge Neuropsychological Test Automated Battery (CANTAB) (www.cambridgecognition.com).

    Correct responses within the shorter time would be treated as better performer.

    Tests would take around 45 minutes per adolescent.


  4. Height (centimetre) [ Time Frame: 85 feeding days ]
    Adolescents height will be measured in centimetre (cm).

  5. Body weight (kilogram) [ Time Frame: 85 feeding days ]
    Adolescents weight will be measured in kilogram (kg)

  6. Waist Circumference (centimetre) [ Time Frame: 85 feeding days ]
    Adolescents waist circumference will be measured in centimetre (cm).

  7. Mid-upper arm circumference (centimetre) [ Time Frame: 85 feeding days ]
    Adolescents mid-upper arm circumference will be measured in centimetre (cm).

  8. Hip circumference (centimetre) [ Time Frame: 85 feeding days ]
    Adolescents hip circumference will be measured in centimetre

  9. BMI (kg/m^2) [ Time Frame: 85 feeding days ]
    Adolescents BMI (kg/m^2) will be calculated by combining weight and height.



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on self-representation of gender identity.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516734


Contacts
Contact: Diane M DellaValle, PhD, RDN 570-348-6211 ext 2477 ddellavalle@marywood.edu

Sponsors and Collaborators
Carol Henry
Brac
Marywood University
Nutrition International
Investigators
Principal Investigator: Albert Vandenberg, PhD University of Saskatchewan

Responsible Party: Carol Henry, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03516734     History of Changes
Other Study ID Numbers: Bio# 17-177
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carol Henry, University of Saskatchewan:
Iron deficiency
Food-based dietary intervention

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs