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

Not Applicable

Active, not recruiting

• Conditions: Zinc Deficiency; Vitamin A Deficiency; Iron Deficiency
• Interventions: Other: Commercially available non-fortified food crops (MBFC-C); Other: Multiple biofortified food crops (MBFC-Exp)

• Registration Number: NCT02648893
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-07
• Study Start: 2019-02-28
• Primary Completion: 2021-01-13
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-26
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBFC-C	Commercially available non-fortified food crops (MBFC-C)	The MBFC-C (Multiple biofortified food crops - Control) arm will consume the same meals based on non-biofortified (commercially available) food crops.
MBFC-Exp	Multiple biofortified food crops (MBFC-Exp)	The MBFC-Exp (Multiple biofortified food crops - Experimental) arm will consume meals based on biofortified food crops.

Primary Outcome Measures

Name	Time	Method
Physical growth	endline (9 months)	As determined by mid-upper arm circumference (mm) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status	endline (9 months)	Determined by AGP (mg/L) after nine months' intervention.
Immune function	endline (9 months)	As assessed by cytokines and vaccine response after 9 months of intervention.

Trial Locations

Locations (2)

S.N.D.T. Women's University; 🇮🇳 Mumbai, India

Arogyavaram Medical Centre; 🇮🇳 Madanapalle, India