Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India

Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India

In this study, iron- and zinc-biofortified pearl millet will be fed to young children in Mumbai, Maharashtra, India over a period of nine months to measure iron status, growth and immune function in comparison to children receiving non-biofortified pearl millet.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency; Zinc Deficiency
• Intervention / Treatment: Other: FeZnPM; Other: CtrlPM

Detailed Description

Iron deficiency remains a major worldwide public health problem, especially in developing countries such as India. In this randomized study, 223 children aged 12-18 months from Mumbai, Maharashtra, India were fed either iron and zinc-biofortified pearl millet or control pearl millet three times per day, six days per week, for nine months. The goal of this study was to examine the effects of iron and zinc-biofortified millet on markers of iron status, growth, and immune function in this age group. The key outcome measures were biomarkers of iron status, physical growth, and immune function defined as response to measles vaccine. Concentrations of serum ferritin and hemoglobin as well as markers of immune function were assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endpoint). Additionally, we measured concentrations of C-reactive protein (CRP), as iron biomarkers can be influenced by inflammation. Growth was assessed monthly for 9 months and expressed as anthropometric Z-scores.

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Mumbai, India, 400049
    • S.N.D.T. Women's University
  • Karnataka
    • Bengaluru, Karnataka, India, 560 034
      • St. John's Research Institute
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 051
      • Centre for the Study of Social Change-Mumbai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit)
• Hemoglobin ≥9 g/dL

Exclusion Criteria:

• Age less than 12 months, 0 days or older than 18 months, 30 days (at time of screening/baseline visit)
• Hemoglobin < 9 g/dL and/or hemoglobinopathy
• Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score < -3)
• Prior diagnoses of HIV/AIDS or Tuberculosis, or Current diagnosis of HIV/AIDS, malaria, Dengue fever, Tuberculosis requiring >1 day hospitalization
• Children who do not have a caretaker to bring him/her to feeding center
• Possibility of migrating out of the slum dwelling for longer than 4 weeks
• Prior or current consumption of iron or zinc supplements in the past 1 year
• Any known dietary allergies

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FeZnPM; The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).	Other: FeZnPM; Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.; Other Names: biofortified pearl millet, bajra, ICTP8203-Fe
Active Comparator: CtrlPM; The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.	Other: CtrlPM; Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.; Other Names: bajra, pearl millet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin (g/dL)	As determined by hemoglobin concentration	Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Hemoglobin (g/dL)	As determined by hemoglobin concentration	Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status	Determined by serum ferritin	Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status	Determined by serum ferritin	Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status BRINDA Adjusted	Determined by serum ferritin BRINDA adjusted	Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status BRINDA Adjusted	Serum ferritin BRINDA adjusted	Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth	Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting.	Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth	Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting.	Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth	Full scale name: Weight-for-age Z-score (child's body weight as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates underweight.	Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth	Full scale name: Weight-for-age Z-score (child's body weight as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates underweight.	Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Immune Function	Immune responses primarily defined as protective anti-measles IgG titers (>16.5 AU/mL).	Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Immune Function	Immune responses primarily defined as response to measles vaccine	Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	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 be assessed.	Midline serial assessment/sample between months 2-7, in a subset
Cognitive function	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 be assessed.	Endline (nine months) in a subset

Collaborators and Investigators

• Sponsor: Cornell University
• Collaborators: St. John's Research Institute; SNDT Women's University; Center for the Study of Social Change
• Investigators: Principal Investigator: Saurabh Mehta, MBBS, ScD, Cornell University; Principal Investigator: Jere D. Haas, Ph.D., Cornell University; Principal Investigator: Shobha Udipi, Ph.D., SNDT Women's University; Principal Investigator: Julia L. Finkelstein, Sc.D., Cornell University; Principal Investigator: Richard L. Canfield, Ph.D., Cornell University; Principal Investigator: Padmini Ghugre, SNDT Women's University; Principal Investigator: R. Potdar, Centre for the Study of Social Change-Mumbai; Principal Investigator: Anura Kurpad, St. John's Research Institute

Publications and helpful links

General Publications

• Huey SL, Finkelstein JL, Venkatramanan S, Udipi SA, Ghugre P, Thakker V, Thorat A, Potdar RD, Chopra HV, Kurpad AV, Haas JD, Mehta S. Prevalence and Correlates of Undernutrition in Young Children Living in Urban Slums of Mumbai, India: A Cross Sectional Study. Front Public Health. 2019 Jul 12;7:191. doi: 10.3389/fpubh.2019.00191. eCollection 2019.
• Mehta S, Finkelstein JL, Venkatramanan S, Huey SL, Udipi SA, Ghugre P, Ruth C, Canfield RL, Kurpad AV, Potdar RD, Haas JD. Effect of iron and zinc-biofortified pearl millet consumption on growth and immune competence in children aged 12-18 months in India: study protocol for a randomised controlled trial. BMJ Open. 2017 Nov 14;7(11):e017631. doi: 10.1136/bmjopen-2017-017631.
• Mehta S, Huey SL, Ghugre PS, Potdar RD, Venkatramanan S, Krisher JT, Ruth CJ, Chopra HV, Thorat A, Thakker V, Johnson L, Powis L, Raveendran Y, Haas JD, Finkelstein JL, Udipi SA; Project Sabal. A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12 to 18 months living in urban slums. Clin Nutr. 2022 Apr;41(4):937-947. doi: 10.1016/j.clnu.2022.02.014. Epub 2022 Feb 24.
• Mehta S, Huey SL, Ghugre PS, Potdar RD, Venkatramanan S, Krisher JT, Ruth CJ, Chopra HV, Thorat A, Thakker V, Johnson L, Powis L, Raveendran Y, Rajagopalan K, Haas JD, Finkelstein JL, Udipi SA; Project Sabal. A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12-18 months living in urban slums. Clin Nutr. 2026 Feb 9;59:106517. doi: 10.1016/j.clnu.2025.11.002. Online ahead of print.
• Huey SL, Venkatramanan S, Udipi SA, Finkelstein JL, Ghugre P, Haas JD, Thakker V, Thorat A, Salvi A, Kurpad AV, Mehta S. Acceptability of Iron- and Zinc-Biofortified Pearl Millet (Dhanashakti)-Based [corrected] Complementary Foods among Children in an Urban Slum of Mumbai, India. Front Nutr. 2017 Aug 25;4:39. doi: 10.3389/fnut.2017.00039. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): July 16, 2018
• Study Completion (Actual): July 16, 2018

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (Estimated): September 8, 2014

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: children; zinc; trial; India; randomized; iron; pearl millet
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Nutritional and Metabolic Diseases; Iron Deficiencies
• Other Study ID Numbers: IRB #: 1403004556

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No