Status:
COMPLETED
Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India
Lead Sponsor:
Cornell University
Collaborating Sponsors:
SNDT Women's University
St. John's Research Institute
Conditions:
Iron Deficiency
Zinc Deficiency
Eligibility:
All Genders
12-18 years
Phase:
NA
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 ...
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, Maharas...
Eligibility Criteria
Inclusion
- Age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit)
- Hemoglobin ≥9 g/dL
Exclusion
- 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
Key Trial Info
Start Date :
May 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2018
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT02233764
Start Date
May 8 2017
End Date
July 16 2018
Last Update
January 30 2019
Active Locations (3)
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1
Centre for the Study of Social Change-Mumbai
Mumbai, Maharashtra, India, 400 051
2
St. John's Research Institute
Karnataka, India, 560 034
3
S.N.D.T. Women's University
Mumbai, India, 400049