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

• ClinicalTrials.gov Identifier: NCT02233764
• Recruitment Status: Completed
• First Posted: September 8, 2014
• Last Update Posted: January 30, 2019
• Sponsor: Cornell University
• Collaborators: SNDT Women's University; St. John's Research Institute; Center for the Study of Social Change
• Information provided by (Responsible Party): Cornell University

Tracking Information

• First Submitted Date: September 4, 2014
• First Posted Date: September 8, 2014
• Last Update Posted Date: January 30, 2019
• Actual Study Start Date: May 8, 2017
• Actual Primary Completion Date: July 16, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 3, 2017)

• Iron status [ Time Frame: Midline serial assessment/sample between months 2-7 ]
  Determined by serum ferritin, sTfR, and total body iron
• Iron status [ Time Frame: Endline (nine months) ]
  Determined by serum ferritin, sTfR, and total body iron
• Physical growth [ Time Frame: Midline serial assessment/sample between months 2-7 ]
  As determined by length/height, weight, head circumference, and mid-upper arm circumference.
• Physical growth [ Time Frame: Endline (nine months) ]
  As determined by length/height, weight, head circumference, and mid-upper arm circumference.
• Immune function [ Time Frame: 1 Midline serial assessment/sample between months 2-7 ]
  Measurement of T cell counts and vaccine response ELISA assays.
• Immune function [ Time Frame: Endline (nine months) ]
  Measurement of T cell counts and vaccine response ELISA assays.

Original Primary Outcome Measures (submitted: September 4, 2014)

• Iron status [ Time Frame: Pre-screening, sTfR, total body iron baseline, midline, endline (nine months) ]
  Determined by serum ferritin, sTfR, and total body iron
• Immune function [ Time Frame: Baseline, midline, endline (nine months) ]
  Measurement of both growth capacity of bacterial strain in whole blood and killing capacity of macrophages.
• Cognitive function [ Time Frame: Baseline, midline, endline (nine months) ]
  Bayley III test will be performed to assess specific aspects of memory, attention, and processing speed as well as assessment of higherintegrative cognitive abilities that require multiple specific functions.
• Physical growth [ Time Frame: Pre-screening, baseline, midline, endline (nine months) ]
  As determined by length/height, weight, head circumference, and mid-upper arm circumference.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: October 3, 2017)

• Cognitive function [ Time Frame: Midline serial assessment/sample between months 2-7, in a subset ]
  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.
• Cognitive function [ Time Frame: Endline (nine months) in a subset ]
  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.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India
• Official Title: Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India
• 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 growth and immune function in comparison to children receiving non-biofortified pearl millet.
• Detailed Description: Iron and zinc deficiency remain a major worldwide public health problem, especially in developing countries such as India. In this randomized study, 700 children aged 12-18 months from Mumbai, Maharashtra, India will be 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 is to examine the effects of iron and zinc biofortified millet on immune function, growth, and cognitive function in this age group. The key outcome measures are biomarkers of iron and zinc status, growth, and immune function. Serum concentrations of hemoglobin, ferritin, serum transferrin receptor, and zinc 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 in a subset, multiple specific aspects of memory, attention, and processing speed 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Other

Condition

• Iron Deficiency
• Zinc Deficiency

Intervention

• 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 Name: biofortified pearl millet, bajra, ICTP8203-Fe
• 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 Name: bajra, pearl millet

Study Arms

• Experimental: FeZnPM
  The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
  Intervention: Other: FeZnPM
• 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.
  Intervention: Other: CtrlPM

Publications *

• 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.
• 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. Erratum In: BMJ Open. 2018 Jan 9;8(1):e017631corr1. BMJ Open. 2018 Oct 2;8(10):e017631corr2.
• 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. Erratum In: Front Nutr. 2018 Oct 18;5:92.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 29, 2019): 223
• Original Estimated Enrollment (submitted: September 4, 2014): 700
• Actual Study Completion Date: July 16, 2018
• Actual Primary Completion Date: July 16, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Months to 18 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT02233764
• Other Study ID Numbers: IRB #: 1403004556
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Cornell University
• Original Responsible Party: Same as current
• Current Study Sponsor: Cornell University
• Original Study Sponsor: Same as current

Collaborators

• SNDT Women's University
• St. John's Research Institute
• 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: 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

• PRS Account: Cornell University
• Verification Date: January 2019