None listed
Conditions
Interventions
Intervention1: Interventional or Experimental arm: FeZnPM
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).: Iron and zinc biofortified pearl millet will be consumed
Sponsors
Cornell University
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Age 9 to 15 months (at time of pre-screening) Serum ferritin Plasma zinc < 105 µg/dL
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Age less than 10 months or older than 15 months (at time of pre-screening) Hemoglobin Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score Prior known or current diagnoses of HIV/AIDS, Malaria, Dengue fever, thrice, Tuberculosis Children who do not have a caretaker to bring him/her to feeding center twice per day Possibility of migrating out of the slum dwelling Prior or current consumption of iron or zinc supplements Any known dietary allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures are biomarkers iron and zinc status determined by serum ferritin, sTfR, serum zinc, and total body ironTimepoint: The time points these will be assessed are at screening (prior to enrolment), baseline (prior to intervention), midline (during months 2-8), and endline (post-intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric measurements as determined by length/height, weight, head circumference, and mid-upper-arm circumference.Timepoint: Baseline, Midline, and Endline (nine months);Cognitive outcomes: Bayley III test will be performed to determine specific aspects of memory, attention, and processing speed as well as assessment of higher integrative cognitive abilities that require multiple specific functions.Timepoint: Baseline, Midline, and Endline (nine months);Immune function tests: Measurement of both growth capacity of bacterial strain in whole blood and killing capacity of macrophages.Timepoint: Baseline, Midline, and Endline (nine months) | — |
Countries
India
Contacts
Public ContactDr Shobha A Udipi
Saint Johns Research Institute
Outcome results
None listed