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

Iron Deficiency Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02648893
• Other study ID #: IRB #: 1508005782
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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)

Related Conditions & MeSH terms

• Iron Deficiency
• Night Blindness
• Vitamin A Deficiency
• Zinc Deficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Arogyavaram Medical Centre	Madanapalle
India	S.N.D.T. Women's University	Mumbai

Sponsors (3)

Lead Sponsor	Collaborator
Cornell University	Arogyavaram Medical Centre, SNDT Women's University

Country where clinical trial is conducted

India, 

Outcome

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