(PO15-34-22) A Randomized Trial of Iron-Biofortified Pearl Millet-Based Complementary Feeding in Children Aged 12 to 18 Months Living in Urban Slums in India

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Presenting Author(s)

Samantha L. Huey, PhD
– Postdoctoral Associate, Division of Nutritional Sciences, Cornell University, Ithaca, New York, United States

Co-Author(s)

PG

Padmini Ghugre, PhD
– SNDT Women's University, Mumbai, Maharashtra, India
RP

Ramesh D. Potdar, MD
– Centre For The Study Of Social Change, Mumbai, Maharashtra, India
SV

Sudha Venkatramanan, PhD
– Division of Nutritional Sciences, Cornell University, Ithaca, New York, United States
JK

Jesse Krisher, BS
– Statistical Analyst, Cornell University, Ithaca, New York, United States
CR

Caleb J. Ruth
– Data Performance, LLC
HC

Harsha V. Chopra
– Centre for the Study of Social Change
AT

Aparna Thorat, MS
– SNDT Women's University, Mumbai, Maharashtra, India
VT

Varsha M. Thakker, MS
– SNDT University, Mumbai, Maharashtra, India
LJ

Lynn M. Johnson
– Cornell University
LP

Laura E. Powis
– Cornell University
YR

Yadurshini Raveendran
– Cornell University
JH

Jere D. Haas, PhD
– Cornell University, Ithaca, New York, United States
JF

Julia L. Finkelstein, MPH, SM, ScD
– Assistant Professor, Cornell University, Ithaca, New York, United States
SU

Shobha A. Udipi, PhD
– Kasturba Health Society's Medical Research Centre, Mumbai, Maharashtra, India
SM

Saurabh Mehta, MBBS, ScD
– Janet and Gordon Lankton Professor, Division of Nutritional Sciences, Cornell University, Ithaca, New York, United States

Disclosure(s):

Samantha L. Huey, PhD: No relevant financial relationship(s) with ineligible companies to disclose.

Objectives: To determine the efficacy of iron-biofortified pearl millet (FePM, Dhanashakti, ICTP-8203Fe)-based complementary feeding on iron status and growth, in children living in urban slums of Mumbai, India.

Methods: This randomized controlled feeding trial of FePM was conducted among 223 children aged 12 to 18 months who were not severely anemic (hemoglobin (Hb) ≥9.0 g/dL) (Clinicaltrials.gov ID: NCT02233764). Children were randomized to receive either complementary foods prepared from FePM or conventional non-biofortified pearl millet (CPM) daily for 9 months. Iron status (Hb, serum ferritin (SF)), and anthropometric indicators (i.e., length, weight, head, mid-upper arm circumferences, triceps and subscapular skinfolds) were evaluated at enrollment and throughout the trial. World Health Organization (WHO) anthropometric Z-scores were calculated using WHO growth standards. Primary outcomes were Hb and SF concentrations, and growth, defined as WHO Z-scores. An intent to treat approach was used for analyses. We used the Hodges–Lehmann–Sen test to assess the change in primary outcomes between baseline and the last visit and report corresponding 95% confidence intervals.

Results: At baseline, 67.7% of children were anemic (Hb < 11.0 g/dL) and 59.6% were iron-deficient (SF < 12.0 µg/L). FePM did not significantly increase iron biomarkers or improve growth, compared to CPM. In subgroup analyses, FePM improved hemoglobin concentrations in male children, and in children with iron deficiency or iron depletion (SF < 25.0 µg/L) at baseline, compared to CPM.

Conclusions: Daily consumption of FePM-based complementary foods did not significantly improve iron status or growth in children living in this population. However, the intervention significantly improved hemoglobin concentrations among male children and individuals who were iron-deficient or iron-depleted at baseline.

Funding Sources: HarvestPlus