Status:
UNKNOWN
Effects of Complementary Feeding of Eggs on Infant Development and Growth in Guatemala: The Saqmolo Study
Lead Sponsor:
Academy of Nutrition and Dietetics
Collaborating Sponsors:
Wuqu' Kawoq, Maya Health Alliance
Think Healthy Group, Inc.
Conditions:
Growth
Development; Delayed
Eligibility:
All Genders
6-9 years
Phase:
NA
Brief Summary
The specific aims of this study are: In a randomized controlled trial, the investigators will evaluate the impact of daily egg consumption during the complementary feeding period in addition to the l...
Detailed Description
Background: Approximately 150 million children, or roughly one-quarter of children worldwide, experience stunting (low height-for-age), while 20% are underweight.1 World-wide, undernutrition is estima...
Eligibility Criteria
Inclusion
- Infants who are 6.0-9.0 months of age at baseline
- At least one caregiver willing to provide oral informed consent
- Planned residence in the study area for approximately the next 18 months
- Singleton birth
Exclusion
- Infants with moderate to severe acute malnutrition (weight-for-length z-score \< -2)
- Infants with severe anemia (Hgb \<7 g/dL per WHO guidelines, with adjustments for altitude as necessary)
- Infants with a chronic medical condition that affects growth (e.g., congenital heart disease, genetic condition) as determined by the MHA staff physician
- Infants whose caregivers have cognitive or other impairments that prevent them from being able to provide informed consent or to reliably provide information required for the developmental assessments
- Infants with a known egg allergy
- Infants with recalcitrant, moderate-to-severe atopic dermatitis
- Infants with a history of anaphylaxis or serious allergic reaction to any substance requiring emergency medical care
- Concurrent participation in any other clinical trial
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04316221
Start Date
April 1 2021
End Date
September 30 2023
Last Update
May 22 2023
Active Locations (1)
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1
Wuqu' Kawoq/Maya Health Alliance
Tecpán Guatemala, Departamento de Chimaltenango, Guatemala