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

Cornell University

Status: Active, not recruiting

Conditions: Iron Deficiency; Vitamin A Deficiency; Zinc Deficiency

Treatments: Other: Multiple biofortified food crops (MBFC-Exp); Other: Commercially available non-fortified food crops (MBFC-C)

Study type: Interventional

Funder types: Other

Identifiers

NCT02648893

IRB #: 1508005782

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

MBFC-Exp

Experimental group

Description:

The MBFC-Exp (Multiple biofortified food crops - Experimental) arm will consume meals based on biofortified food crops.

Treatment:

Other: Multiple biofortified food crops (MBFC-Exp)

MBFC-C

Active Comparator group

Description:

The MBFC-C (Multiple biofortified food crops - Control) arm will consume the same meals based on non-biofortified (commercially available) food crops.

Treatment:

Other: Commercially available non-fortified food crops (MBFC-C)