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
|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|
|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.|
|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|
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.
- 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
- 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.
- 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.
- 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.
- Height (centimetre) [ Time Frame: 85 feeding days ]Adolescents height will be measured in centimetre (cm).
- Body weight (kilogram) [ Time Frame: 85 feeding days ]Adolescents weight will be measured in kilogram (kg)
- Waist Circumference (centimetre) [ Time Frame: 85 feeding days ]Adolescents waist circumference will be measured in centimetre (cm).
- Mid-upper arm circumference (centimetre) [ Time Frame: 85 feeding days ]Adolescents mid-upper arm circumference will be measured in centimetre (cm).
- Hip circumference (centimetre) [ Time Frame: 85 feeding days ]Adolescents hip circumference will be measured in centimetre
- BMI (kg/m^2) [ Time Frame: 85 feeding days ]Adolescents BMI (kg/m^2) will be calculated by combining weight and height.
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
|Contact: Diane M DellaValle, PhD, RDN||570-348-6211 ext firstname.lastname@example.org|
|Principal Investigator:||Albert Vandenberg, PhD||University of Saskatchewan|