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

May 24, 2023 updated by: Cornell University

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biomarkers of vitamin A, iron, and zinc status
Time Frame: endline (9 months)
Determined by serum ferritin (ng/mL) after nine months' intervention.
endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Time Frame: endline (9 months)
Determined by sTfR (soluble Transferrin Receptor; mg/L) after nine months' intervention.
endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Time Frame: endline (9 months)
Determined by serum retinol (µmol/L) after nine months' intervention.
endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Time Frame: endline (9 months)
Determined by serum zinc (mcg/mL) after nine months' intervention.
endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Time Frame: endline (9 months)
Determined by RBP (Retinol-binding Protein; ng/mL) after nine months' intervention.
endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Time Frame: endline (9 months)
Determined by hemoglobin (g/dL) after nine months' intervention.
endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Time Frame: endline (9 months)
Determined by hepcidin (ng/mL) after nine months' intervention.
endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Time Frame: endline (9 months)
Determined by CRP (mg/L) after nine months' intervention.
endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Time Frame: endline (9 months)
Determined by AGP (mg/L) after nine months' intervention.
endline (9 months)
Physical growth
Time Frame: endline (9 months)
As determined by length/height (cm) after nine months' intervention.
endline (9 months)
Physical growth
Time Frame: endline (9 months)
As determined by weight (kg) after nine months' intervention.
endline (9 months)
Physical growth
Time Frame: endline (9 months)
As determined by head circumference (cm) after nine months' intervention.
endline (9 months)
Physical growth
Time Frame: endline (9 months)
As determined by mid-upper arm circumference (mm) after nine months' intervention.
endline (9 months)
Immune function
Time Frame: endline (9 months)
As assessed by cytokines and vaccine response after 9 months of intervention.
endline (9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Arogyavaram Medical Centre
SNDT Women's University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 13, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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