Effect of high Iron/Zinc Pearl Millet on growth, ability of the body to resist infections (immunity), and mental functioning (cognition) in children aged 12-18 months in India
Not Applicable
Completed
- Registration Number
- CTRI/2015/11/006376
- Lead Sponsor
- Cornell University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 223
Inclusion Criteria
Inclusion Criteria:
Age 9 to 15 months (at time of pre-screening)
Serum ferritin < 20 µg/dL
Plasma zinc < 105 µg/d
Exclusion Criteria
Exclusion Criteria:
Age less than 10 months or older than 15 months (at time of pre-screening)
Hemoglobin < 9 g/dL and/or hemoglobinapathy
Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score < -3)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Anthropometric measurements as determined by length/height, weight, head circumference, and <br/ ><br>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: <br/ ><br>Measurement of both growth capacity of bacterial strain in whole blood and killing capacity of macrophages.Timepoint: Baseline, Midline, and Endline (nine months)