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

NCT02233764 | Completed Results DMC

• 1 other identifier: IRB #: 1403004556
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Iron Deficiency; Zinc Deficiency

Keywords

iron; zinc; pearl millet; India; children; trial; randomized

Outcome Measures

Primary Outcomes (12)

• 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)

Study Arms (2)

FeZnPM

EXPERIMENTAL

The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).

Other: FeZnPM

CtrlPM

ACTIVE COMPARATOR

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

Interventions

FeZnPM OTHER

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.

Also known as: biofortified pearl millet, bajra, ICTP8203-Fe

FeZnPM

CtrlPM OTHER

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.

Also known as: bajra, pearl millet

CtrlPM

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornell University: lead
• SNDT Women's University: collaborator
• Center for the Study of Social Change: collaborator
• St. John's Research Institute: collaborator

Study Sites (3)

St. John's Research Institute

Bengaluru, Karnataka, 560 034, India

Location

Centre for the Study of Social Change-Mumbai

Mumbai, Maharashtra, 400 051, India

Location

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

Mumbai, 400049, India

Location

Related Publications (5)

• 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.

  PMID: 29138201 BACKGROUND

• 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.

  PMID: 35299084 RESULT

• 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 Apr;59:106517. doi: 10.1016/j.clnu.2025.11.002. Epub 2026 Feb 9.

  PMID: 41740296 DERIVED

• 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.

  PMID: 31355176 DERIVED

• 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.

  PMID: 28971097 DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Given the urban slum context of this study, participants missed days of feeding and/or were lost to follow-up due to several reasons (see Mehta et al. 2022). Collecting enough whole blood from participants was difficult due to low blood volume, and equipment able to perform multiple assays with limited blood volume was unavailable locally. Tests for primary endpoints were prioritized based on available sample volume and some tests therefore could only be conducted in a subset of samples.

Results Point of Contact

• Title: Dr. Saurabh Mehta
• Organization: Cornell University

smehta@cornell.edu

(607) 255-2640

Study Officials

• Saurabh Mehta, MBBS, ScD

  Cornell University

  PRINCIPAL INVESTIGATOR

• Jere D. Haas, Ph.D.

  Cornell University

  PRINCIPAL INVESTIGATOR

• Julia L. Finkelstein, Sc.D.

  Cornell University

  PRINCIPAL INVESTIGATOR

• Richard L. Canfield, Ph.D.

  Cornell University

  PRINCIPAL INVESTIGATOR

• Shobha Udipi, Ph.D.

  SNDT Women's 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 4, 2014
• First Posted: September 8, 2014
• Study Start: May 8, 2017
• Primary Completion: July 16, 2018
• Study Completion: July 16, 2018
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-02

Locations

IN (3)