Clinical trial NCT02233764: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Zinc Deficiency
Keywords: iron
zinc
pearl millet
India
children
trial
randomized
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: SNDT Women's University
name: St. John's Research Institute
name: Center for the Study of Social Change
First posted: 2014-09-08
Enrollment: 223
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Iron status
timeFrame: Midline serial assessment/sample between months 2-7
measure: Iron status
timeFrame: Endline (nine months)
measure: Physical growth
timeFrame: Midline serial assessment/sample between months 2-7
measure: Physical growth
timeFrame: Endline (nine months)
measure: Immune function
timeFrame: 1 Midline serial assessment/sample between months 2-7
measure: Immune function
timeFrame: Endline (nine months)
Secondary outcomes:
Other outcomes:
measure: Cognitive function
timeFrame: Midline serial assessment/sample between months 2-7, in a subset
measure: Cognitive function
timeFrame: Endline (nine months) in a subset
Locations:
city: Mumbai
country: India
facility: Centre for the Study of Social Change-Mumbai
state: Maharashtra
city: Karnataka
country: India
facility: St. John's Research Institute
city: Mumbai
country: India
facility: S.N.D.T. Women's University
Study officials:
affiliation: Cornell University
name: Saurabh Mehta, MBBS, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: Jere D. Haas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: Julia L. Finkelstein, Sc.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: Richard L. Canfield, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SNDT Women's University
name: Shobha Udipi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SNDT Women's University
name: Padmini Ghugre
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for the Study of Social Change-Mumbai
name: R. Potdar
role: PRINCIPAL_INVESTIGATOR
affiliation: St. John's Research Institute
name: Anura Kurpad
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.