Effect Of Multiple Biofortified Food Crops On Micronutrient Status And Immune Function Among Indian Infants and Their Mothers (MBFC)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Iron Deficiency; Vitamin A Deficiency; Zinc Deficiency
• Intervention / Treatment: Other: Multiple biofortified food crops (MBFC-Exp); Other: Commercially available non-fortified food crops (MBFC-C)

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Madanapalle, India
    • Arogyavaram Medical Centre
  • Mumbai, India, 400049
    • S.N.D.T. Women's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Non-biofortified food crops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers of vitamin A, iron, and zinc status	Determined by serum ferritin (ng/mL) after nine months' intervention.	endline (9 months)
Biomarkers of vitamin A, iron, and zinc status	Determined by sTfR (soluble Transferrin Receptor; mg/L) after nine months' intervention.	endline (9 months)
Biomarkers of vitamin A, iron, and zinc status	Determined by serum retinol (µmol/L) after nine months' intervention.	endline (9 months)
Biomarkers of vitamin A, iron, and zinc status	Determined by serum zinc (mcg/mL) after nine months' intervention.	endline (9 months)
Biomarkers of vitamin A, iron, and zinc status	Determined by RBP (Retinol-binding Protein; ng/mL) after nine months' intervention.	endline (9 months)
Biomarkers of vitamin A, iron, and zinc status	Determined by hemoglobin (g/dL) after nine months' intervention.	endline (9 months)
Biomarkers of vitamin A, iron, and zinc status	Determined by hepcidin (ng/mL) after nine months' intervention.	endline (9 months)
Biomarkers of vitamin A, iron, and zinc status	Determined by CRP (mg/L) after nine months' intervention.	endline (9 months)
Biomarkers of vitamin A, iron, and zinc status	Determined by AGP (mg/L) after nine months' intervention.	endline (9 months)
Physical growth	As determined by length/height (cm) after nine months' intervention.	endline (9 months)
Physical growth	As determined by weight (kg) after nine months' intervention.	endline (9 months)
Physical growth	As determined by head circumference (cm) after nine months' intervention.	endline (9 months)
Physical growth	As determined by mid-upper arm circumference (mm) after nine months' intervention.	endline (9 months)
Immune function	As assessed by cytokines and vaccine response after 9 months of intervention.	endline (9 months)

Collaborators and Investigators

• Sponsor: Cornell University
• Collaborators: Arogyavaram Medical Centre; SNDT Women's University
• Investigators: Principal Investigator: Jere D Haas, PhD, Cornell University; Principal Investigator: Saurabh Mehta, MBBS, ScD, 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

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): January 13, 2021
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimated): January 7, 2016

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: zinc; efficacy; trial; infant; India; iron; vitamin A; biofortified
• Additional Relevant MeSH Terms: Metabolic Diseases; Eye Diseases; Nutrition Disorders; Iron Metabolism Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vision Disorders; Night Blindness; Vitamin A Deficiency; Iron Deficiencies
• Other Study ID Numbers: IRB #: 1508005782

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No