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

NCT ID: NCT02648893

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2023-12-31

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.

Conditions

Vitamin A Deficiency; Iron Deficiency; Zinc Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

MBFC-Exp

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

Group Type: EXPERIMENTAL

Multiple biofortified food crops (MBFC-Exp)

Intervention Type: OTHER

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.

MBFC-C

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Biofortified food crops; Non-biofortified food crops

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)

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SNDT Women's University

OTHER

Sponsor Role: collaborator

Arogyavaram Medical Centre

OTHER

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saurabh Mehta, MBBS, ScD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Julia L. Finkelstein, ScD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Shobha Udipi, PhD

Role: PRINCIPAL_INVESTIGATOR

SNDT Women's University

Bonam Wesley, MBBS

Role: PRINCIPAL_INVESTIGATOR

Arogyavaram Medical Centre

Jere D Haas, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

Arogyavaram Medical Centre

Madanapalle, , India

S.N.D.T. Women's University

Mumbai, , India

Countries

India

Other Identifiers

IRB #: 1508005782

Identifier Type: -

Identifier Source: org_study_id