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Effect Of A Biofortified Food Basket On Micronutrient Status And Immune And Cognitive Function Among Infants In India

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ClinicalTrials.gov Identifier: NCT02648893
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : March 11, 2019
Sponsor:
Collaborators:
SNDT Women's University
Arogyavaram Medical Centre
Information provided by (Responsible Party):
Cornell University

Brief Summary:
In this study, a multiple food crops basket (containing four 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. Lactating women (their mothers) 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 basket (MBFC-Exp) Other: Commercially available four 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, 400 children aged 6-12 months (and their lactating mothers) from Madanapalle, Andhra Pradesh, India will be fed meals based on a multiple food crops basket (containing either four biofortified or commercially-available food crops) three times per day, six days per week, for nine months. Our focus will be to recruit primarily children aged 6-7 months but children between 6 and 12 months will be eligible in case we are not able to recruit adequate number of younger children. The goal of this study is to examine the effects of the biofortified multiple food crops basket 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, attention, and processing speed 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, a Bayley III test will be conducted at the 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 : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effect Of A Biofortified Food Basket On Micronutrient Status And Immune And Cognitive Function In The First 1000 Days Of Life In India
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MBFC-Exp
The MBFC-Exp (four biofortified food crops - Experimental) arm will consume the biofortified multiple food crops basket.
Other: Multiple biofortified food crops basket (MBFC-Exp)
Four 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: four biofortified food crops

Active Comparator: MBFC-C
The MBFC-C (Multiple biofortified food crops - Control) arm will consume the non-biofortified (commercially available) four food crops basket.
Other: Commercially available four food crops (MBFC-C)
The Commercially available food crops arm will consume four commercially available food crops three times per day, six days per week, for 9 months.
Other Name: four 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) ]
    Bayley III test will be performed to assess specific aspects of memory, attention, and processing speed as well as assessment of higher integrative cognitive abilities that require multiple specific functions.



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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6 to 12 months (at enrollment; our focus will be to recruit primarily children aged 6-7 months but children between 6 and 12 months will be eligible in case we are not able to recruit adequate number of younger children)
  • Lactating women

Exclusion Criteria (children):

  • Age less than 6 months or older than 12 months (at time of screening)
  • Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score < -3; see Table 1)
  • Prior known or current diagnoses of HIV/AIDS, Malaria, Dengue fever, Tuberculosis
  • Children who do not have a caregiver to bring him/her to feeding center twice per day
  • 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

Exclusion Criteria (women):

  • Severe anemia
  • Sickness or hospitalization

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


Contacts
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Contact: Saurabh Mehta, MBBS, ScD 607-255-2640 smehta@cornell.edu

Locations
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India
Arogyavaram Medical Centre Recruiting
Madanapalle, India
Contact: Bonam Wesley, MBBS         
S.N.D.T. Women's University Not yet recruiting
Mumbai, India, 400049
Contact: Shobha Udipi    91-22-26608855    drshobaudipi@gmail.com   
Principal Investigator: Shobha Udipi, MSc, PhD         
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     History of Changes
Other Study ID Numbers: IRB #: 1508005782
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 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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Anemia, Iron-Deficiency
Vitamin A Deficiency
Night Blindness
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Micronutrients
Trace Elements
Nutrients
Growth Substances
Physiological Effects of Drugs