Effect Of Multiple Biofortified Food Crops On Micronutrient Status And Immune Function Among Indian Infants and Their Mothers (MBFC)
Primary Purpose
Vitamin A Deficiency, Iron Deficiency, Zinc Deficiency
Status
Active
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Multiple biofortified food crops (MBFC-Exp)
Commercially available non-fortified food crops (MBFC-C)
Sponsored by
About this trial
This is an interventional other trial for Vitamin A Deficiency focused on measuring iron, zinc, vitamin A, biofortified, efficacy, India, infant, trial
Eligibility 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)
Sites / Locations
- Arogyavaram Medical Centre
- S.N.D.T. Women's University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MBFC-Exp
MBFC-C
Arm Description
The MBFC-Exp (Multiple biofortified food crops - Experimental) arm will consume meals based on biofortified food crops.
The MBFC-C (Multiple biofortified food crops - Control) arm will consume the same meals based on non-biofortified (commercially available) food crops.
Outcomes
Primary Outcome Measures
Biomarkers of vitamin A, iron, and zinc status
Determined by serum ferritin (ng/mL) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Determined by sTfR (soluble Transferrin Receptor; mg/L) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Determined by serum retinol (µmol/L) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Determined by serum zinc (mcg/mL) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Determined by RBP (Retinol-binding Protein; ng/mL) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Determined by hemoglobin (g/dL) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Determined by hepcidin (ng/mL) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Determined by CRP (mg/L) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Determined by AGP (mg/L) after nine months' intervention.
Physical growth
As determined by length/height (cm) after nine months' intervention.
Physical growth
As determined by weight (kg) after nine months' intervention.
Physical growth
As determined by head circumference (cm) after nine months' intervention.
Physical growth
As determined by mid-upper arm circumference (mm) after nine months' intervention.
Immune function
As assessed by cytokines and vaccine response after 9 months of intervention.
Secondary Outcome Measures
Full Information
NCT ID
NCT02648893
First Posted
November 23, 2015
Last Updated
May 24, 2023
Sponsor
Cornell University
Collaborators
SNDT Women's University, Arogyavaram Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT02648893
Brief Title
Effect Of Multiple Biofortified Food Crops On Micronutrient Status And Immune Function Among Indian Infants and Their Mothers
Acronym
MBFC
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
January 13, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University
Collaborators
SNDT Women's University, Arogyavaram Medical Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency, Iron Deficiency, Zinc Deficiency
Keywords
iron, zinc, vitamin A, biofortified, efficacy, India, infant, trial
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MBFC-Exp
Arm Type
Experimental
Arm Description
The MBFC-Exp (Multiple biofortified food crops - Experimental) arm will consume meals based on biofortified food crops.
Arm Title
MBFC-C
Arm Type
Active Comparator
Arm Description
The MBFC-C (Multiple biofortified food crops - Control) arm will consume the same meals based on non-biofortified (commercially available) food crops.
Intervention Type
Other
Intervention Name(s)
Multiple biofortified food crops (MBFC-Exp)
Other Intervention Name(s)
Biofortified food crops
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Commercially available non-fortified food crops (MBFC-C)
Other Intervention Name(s)
Non-biofortified food crops
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biomarkers of vitamin A, iron, and zinc status
Description
Determined by serum ferritin (ng/mL) after nine months' intervention.
Time Frame
endline (9 months)
Title
Biomarkers of vitamin A, iron, and zinc status
Description
Determined by sTfR (soluble Transferrin Receptor; mg/L) after nine months' intervention.
Time Frame
endline (9 months)
Title
Biomarkers of vitamin A, iron, and zinc status
Description
Determined by serum retinol (µmol/L) after nine months' intervention.
Time Frame
endline (9 months)
Title
Biomarkers of vitamin A, iron, and zinc status
Description
Determined by serum zinc (mcg/mL) after nine months' intervention.
Time Frame
endline (9 months)
Title
Biomarkers of vitamin A, iron, and zinc status
Description
Determined by RBP (Retinol-binding Protein; ng/mL) after nine months' intervention.
Time Frame
endline (9 months)
Title
Biomarkers of vitamin A, iron, and zinc status
Description
Determined by hemoglobin (g/dL) after nine months' intervention.
Time Frame
endline (9 months)
Title
Biomarkers of vitamin A, iron, and zinc status
Description
Determined by hepcidin (ng/mL) after nine months' intervention.
Time Frame
endline (9 months)
Title
Biomarkers of vitamin A, iron, and zinc status
Description
Determined by CRP (mg/L) after nine months' intervention.
Time Frame
endline (9 months)
Title
Biomarkers of vitamin A, iron, and zinc status
Description
Determined by AGP (mg/L) after nine months' intervention.
Time Frame
endline (9 months)
Title
Physical growth
Description
As determined by length/height (cm) after nine months' intervention.
Time Frame
endline (9 months)
Title
Physical growth
Description
As determined by weight (kg) after nine months' intervention.
Time Frame
endline (9 months)
Title
Physical growth
Description
As determined by head circumference (cm) after nine months' intervention.
Time Frame
endline (9 months)
Title
Physical growth
Description
As determined by mid-upper arm circumference (mm) after nine months' intervention.
Time Frame
endline (9 months)
Title
Immune function
Description
As assessed by cytokines and vaccine response after 9 months of intervention.
Time Frame
endline (9 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saurabh Mehta, MBBS, ScD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julia L. Finkelstein, ScD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shobha Udipi, PhD
Organizational Affiliation
SNDT Women's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bonam Wesley, MBBS
Organizational Affiliation
Arogyavaram Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jere D Haas, PhD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arogyavaram Medical Centre
City
Madanapalle
Country
India
Facility Name
S.N.D.T. Women's University
City
Mumbai
ZIP/Postal Code
400049
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect Of Multiple Biofortified Food Crops On Micronutrient Status And Immune Function Among Indian Infants and Their Mothers
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