Randomized Placebo-Controlled Trial (RPCT) of Maize/Zinc in Guatemala
2 other identifiers
interventional
420
1 country
1
Brief Summary
Malnutrition is a serious health problem in the developing world. This study looks at the effects of changing the type of basic food staple (corn) used in Guatemala and infant zinc supplementation on infants' growth, development, and illnesses from infectious diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2003
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 3, 2004
CompletedFirst Posted
Study publicly available on registry
December 6, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedDecember 17, 2013
December 1, 2013
December 3, 2004
December 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Infant Maize/Zn Supplementation Trial:
Linear growth velocity
Zn Homeostasis Studies:
Measures of zinc homeostasis
Secondary Outcomes (5)
Infant Maize/Zn Supplementation Trial:
Weight gain
Morbidity
Infant neurodevelopment
Maternal and infant biomarkers
Interventions
Eligibility Criteria
You may qualify if:
- Informed consent of mother
- Mother between the ages of 18 and 40 years
- Mother typically eats homemade tortillas
- Mother typically eats a minimum of 15 homemade tortillas per day.
- Mother resides in a community served by the Comalapa, Chimaltenango, Community Health Center in the Western Highlands of Guatemala
You may not qualify if:
- Other member of the dwelling unti already enrolled in the study.
- Mother has more than eight living children.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NICHD Global Network for Women's and Children's Healthlead
- Global Network for Women's and Children's Health Researchcollaborator
- Bill and Melinda Gates Foundationcollaborator
- Fogarty International Center of the National Institute of Healthcollaborator
- National Center for Complementary and Integrative Health (NCCIH)collaborator
- National Institute of Dental and Craniofacial Research (NIDCR)collaborator
- National Cancer Institute (NCI)collaborator
- RTI Internationalcollaborator
- University of Colorado, Denvercollaborator
- Center for Studies of Sensory Impairment, Aging and Metabolismcollaborator
- Foundation for Alimentation and Nutrition, Central America and Panamacollaborator
- USDA Beltsville Human Nutrition Research Centercollaborator
Study Sites (1)
Community
Comalapa, Guatemala
Related Publications (1)
Hambidge KM, Mazariegos M, Kindem M, Wright LL, Cristobal-Perez C, Juarez-Garcia L, Westcott JE, Goco N, Krebs NF. Infant stunting is associated with short maternal stature. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):117-9. doi: 10.1097/MPG.0b013e3182331748.
PMID: 21866055DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Hambidge, MD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2004
First Posted
December 6, 2004
Study Start
March 1, 2003
Study Completion
April 1, 2007
Last Updated
December 17, 2013
Record last verified: 2013-12