NCT02648893

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
3.1 years until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2021

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

November 23, 2015

Last Update Submit

May 24, 2023

Conditions

Vitamin A DeficiencyIron DeficiencyZinc Deficiency

Keywords

ironzincvitamin AbiofortifiedefficacyIndiainfanttrial

Outcome Measures

Primary Outcomes (14)

  • Biomarkers of vitamin A, iron, and zinc status

    Determined by serum ferritin (ng/mL) after nine months' intervention.

    endline (9 months)

  • Biomarkers of vitamin A, iron, and zinc status

    Determined by sTfR (soluble Transferrin Receptor; mg/L) after nine months' intervention.

    endline (9 months)

  • Biomarkers of vitamin A, iron, and zinc status

    Determined by serum retinol (µmol/L) after nine months' intervention.

    endline (9 months)

  • Biomarkers of vitamin A, iron, and zinc status

    Determined by serum zinc (mcg/mL) after nine months' intervention.

    endline (9 months)

  • Biomarkers of vitamin A, iron, and zinc status

    Determined by RBP (Retinol-binding Protein; ng/mL) after nine months' intervention.

    endline (9 months)

  • Biomarkers of vitamin A, iron, and zinc status

    Determined by hemoglobin (g/dL) after nine months' intervention.

    endline (9 months)

  • Biomarkers of vitamin A, iron, and zinc status

    Determined by hepcidin (ng/mL) after nine months' intervention.

    endline (9 months)

  • Biomarkers of vitamin A, iron, and zinc status

    Determined by CRP (mg/L) after nine months' intervention.

    endline (9 months)

  • Biomarkers of vitamin A, iron, and zinc status

    Determined by AGP (mg/L) after nine months' intervention.

    endline (9 months)

  • Physical growth

    As determined by length/height (cm) after nine months' intervention.

    endline (9 months)

  • Physical growth

    As determined by weight (kg) after nine months' intervention.

    endline (9 months)

  • Physical growth

    As determined by head circumference (cm) after nine months' intervention.

    endline (9 months)

  • Physical growth

    As determined by mid-upper arm circumference (mm) after nine months' intervention.

    endline (9 months)

  • Immune function

    As assessed by cytokines and vaccine response after 9 months of intervention.

    endline (9 months)

Study Arms (2)

MBFC-Exp

EXPERIMENTAL

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

Other: Multiple biofortified food crops (MBFC-Exp)

MBFC-C

ACTIVE COMPARATOR

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)

Interventions

Multiple biofortified food crops (MBFC-Exp)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.

Also known as: Biofortified food crops
MBFC-Exp
Commercially available non-fortified food crops (MBFC-C)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.

Also known as: Non-biofortified food crops
MBFC-C

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children: Age 6 to 24 months (at enrollment);
  • Mothers: Biological mothers of included children.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arogyavaram Medical Centre

Madanapalle, India

Location

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

Mumbai, 400049, India

Location

MeSH Terms

Conditions

Vitamin A DeficiencyIron Deficiencies

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesIron Metabolism DisordersMetabolic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Jere D Haas, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2015

First Posted

January 7, 2016

Study Start

February 28, 2019

Primary Completion

January 13, 2021

Study Completion

December 1, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IN(2)