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Effect Of Multiple Biofortified Food Crops On Micronutrient Status, Immune, And Cognitive Function Among Indian Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02648893
Recruitment Status : Active, not recruiting
First Posted : January 7, 2016
Last Update Posted : October 28, 2019
Sponsor:
Collaborators:
SNDT Women's University
Arogyavaram Medical Centre
Information provided by (Responsible Party):
Cornell University

Brief Summary:
In this study, meals based on multiple food crops (containing either biofortified or commercially-available food crops) will be fed to young children in Madanapalle, Andhra Pradesh, India over a period of nine months to measure growth, cognitive changes, and immune function in comparison to children receiving non-biofortified crops. Mothers of the participating children will also be included in the study.

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency Iron Deficiency Zinc Deficiency Other: Multiple biofortified food crops (MBFC-Exp) Other: Commercially available non-fortified food crops (MBFC-C) Not Applicable

Detailed Description:
Iron, zinc, and vitamin A deficiency remain a major worldwide public health problem especially in developing countries such as India. In this randomized study, 200 children aged 6-12 months (and their lactating mothers) from Madanapalle, Andhra Pradesh, India will be fed meals based on (either biofortified or commercially-available) multiple food crops three times per day, six days per week, for nine months. We will recruit children from 6 - 24 months of age. The goal of this study is to examine the effects of the biofortified multiple food crops on immune function, growth, and cognitive function in this age group. The key outcome measures are biomarkers of vitamin A, iron and zinc status, growth (anthropometric z-scores), and immune and cognitive function. Nutrient biomarkers will be assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endline). Additionally, we will measure concentrations of C-reactive protein (CRP) and alpha 1-acid glycoprotein (AGP), as iron and zinc biomarkers can be influenced by inflammation. To assess cognitive function, multiple specific aspects of memory and attention will be assessed. Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will also be assessed. In addition, the Development Assessment Scales for Indian Infants (DASII) test will be conducted at baseline, intermediate, and endline assessments to obtain a broad measure of attainment of developmental milestones that can be used to compare the characteristics of this cohort with those reported in the literature.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effect Of Delivering Micronutrients Through Multiple Biofortified Food Crops On Nutritional Status And Immune Function: A Feeding Trial In The First 1000 Days Of Life In India
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MBFC-Exp
The MBFC-Exp (Multiple biofortified food crops - Experimental) arm will consume meals based on biofortified food crops.
Other: Multiple biofortified food crops (MBFC-Exp)
Meals from three biofortified food crops will be consumed by children (and potentially their lactating mothers) three times per day, six days per week, for 9 months.
Other Name: Biofortified food crops

Active Comparator: MBFC-C
The MBFC-C (Multiple biofortified food crops - Control) arm will consume the same meals based on non-biofortified (commercially available) food crops.
Other: Commercially available non-fortified food crops (MBFC-C)
This arm will consume meals based on three commercially available (non-biofortified) food crops three times per day, six days per week, for 9 months.
Other Name: Non-biofortified food crops




Primary Outcome Measures :
  1. Biomarkers of vitamin A, iron, and zinc status [ Time Frame: endline (9 months) ]
    Determined by serum ferritin (ng/mL) after nine months' intervention.

  2. Biomarkers of vitamin A, iron, and zinc status [ Time Frame: endline (9 months) ]
    Determined by sTfR (soluble Transferrin Receptor; mg/L) after nine months' intervention.

  3. Biomarkers of vitamin A, iron, and zinc status [ Time Frame: endline (9 months) ]
    Determined by serum retinol (µmol/L) after nine months' intervention.

  4. Biomarkers of vitamin A, iron, and zinc status [ Time Frame: endline (9 months) ]
    Determined by serum zinc (mcg/mL) after nine months' intervention.

  5. Biomarkers of vitamin A, iron, and zinc status [ Time Frame: endline (9 months) ]
    Determined by RBP (Retinol-binding Protein; ng/mL) after nine months' intervention.

  6. Biomarkers of vitamin A, iron, and zinc status [ Time Frame: endline (9 months) ]
    Determined by hemoglobin (g/dL) after nine months' intervention.

  7. Biomarkers of vitamin A, iron, and zinc status [ Time Frame: endline (9 months) ]
    Determined by hepcidin (ng/mL) after nine months' intervention.

  8. Biomarkers of vitamin A, iron, and zinc status [ Time Frame: endline (9 months) ]
    Determined by CRP (mg/L) after nine months' intervention.

  9. Biomarkers of vitamin A, iron, and zinc status [ Time Frame: endline (9 months) ]
    Determined by AGP (mg/L) after nine months' intervention.

  10. Physical growth [ Time Frame: endline (9 months) ]
    As determined by length/height (cm) after nine months' intervention.

  11. Physical growth [ Time Frame: endline (9 months) ]
    As determined by weight (kg) after nine months' intervention.

  12. Physical growth [ Time Frame: endline (9 months) ]
    As determined by head circumference (cm) after nine months' intervention.

  13. Physical growth [ Time Frame: endline (9 months) ]
    As determined by mid-upper arm circumference (mm) after nine months' intervention.

  14. Immune function [ Time Frame: endline (9 months) ]
    As assessed by in-vitro whole blood assays after 9 months of intervention.

  15. Cognitive function [ Time Frame: endline (9 months) ]
    Development Assessment Scale in Indian Infants (DASII) test will be performed to assess specific aspects of memory and attentionas well as assessment higher integrative cognitive abilities that require multiple specific functions.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Children: Age 6 to 24 months (at enrollment);

Mothers: Biological mothers of included children.

Exclusion Criteria

Children

  • Age below 6 months or above 24 months (at time of screening);
  • Hemoglobin <9 g/dL (at time of screening);
  • Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score < -3);
  • Prior known or current diagnoses of HIV/AIDS, Malaria, Dengue fever, Tuberculosis;
  • Children whose biological mother is unable to bring her/him to feeding center daily;
  • Possibility of migrating out of the study catchment area for more than 4 consecutive weeks;
  • Prior or current consumption of iron, zinc, and/or vitamin A supplements;
  • Any known dietary allergies.

Mothers

- Severe anemia (Hemoglobin <7g/ dL)


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): NCT02648893


Locations
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India
Arogyavaram Medical Centre
Madanapalle, India
S.N.D.T. Women's University
Mumbai, India, 400049
Sponsors and Collaborators
Cornell University
SNDT Women's University
Arogyavaram Medical Centre
Investigators
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Principal Investigator: Jere D. Haas, PhD Cornell University
Principal Investigator: Julia L. Finkelstein, ScD Cornell University
Principal Investigator: Shobha Udipi, PhD SNDT Women's University
Principal Investigator: Bonam Wesley, MBBS Arogyavaram Medical Centre

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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT02648893    
Other Study ID Numbers: IRB #: 1508005782
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cornell University:
iron
zinc
vitamin A
biofortified
efficacy
India
infant
trial
Additional relevant MeSH terms:
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Night Blindness
Vitamin A Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs