Randomized Placebo-Controlled Trial (RPCT) of Maize/Zinc in Guatemala
NCT ID: NCT00098202
Last Updated: 2013-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
420 participants
INTERVENTIONAL
2003-03-31
2007-04-30
Brief Summary
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Detailed Description
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The primary outcome measurement is linear growth velocity between 6 and 12 months. Secondary outcomes are weight gain, diarrheal incidence/prevalence and infant neurodevelopmental measures. Optional maternal and infant biochemical data will be collected from a convenience sample comprised of willing participants.
One additional component to this study is to collect information on the nutritional status of the women receiving low-phytate vs. control maize and the infants enrolled in this study.
The current protocol for infants in this study specifies measurements of exchangeable zinc pool (EZP) at 6 and 12 months of age; in order to lessen the burden of study participation we plan to conduct the metabolic studies in infants at only nine months of age. In addition to decreasing the number of infant studies, this change will enable families who are only participating in the metabolic studies (not simultaneously enrolled in the sibling cohort) to cease all study demands at the end of the nine month measurement (an overall decrease of three months in study participation).
The primary outcome measure for this study is the quantity of zinc absorbed (mg/day)from complementary foods and a Zn supplement at age 9 months. The rationale for measures of zinc absorption in infants is that the low phytate complementary feeding is expected to have a beneficial public health effect only if it results in enhanced mineral, especially zinc, absorption. Therefore, confirmation of increased zinc absorption can be regarded as the first logical stage of any efficacy study.
The sample size of 420 is required in order to observe a 6% increase in growth rates for Zn supplemented infants compared to placebo treated infants within each maize group with 80% power.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Interventions
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Low phytic acid maize
Zinc
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Mother has more than eight living children.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Global Network for Women's and Children's Health Research
OTHER
Bill and Melinda Gates Foundation
OTHER
Fogarty International Center of the National Institute of Health
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
National Institute of Dental and Craniofacial Research (NIDCR)
NIH
National Cancer Institute (NCI)
NIH
RTI International
OTHER
University of Colorado, Denver
OTHER
Center for Studies of Sensory Impairment, Aging and Metabolism
OTHER
Foundation for Alimentation and Nutrition, Central America and Panama
OTHER
USDA Beltsville Human Nutrition Research Center
FED
NICHD Global Network for Women's and Children's Health
NETWORK
Responsible Party
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Principal Investigators
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Michael Hambidge, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Community
Comalapa, , Guatemala
Countries
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References
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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.
Related Links
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Global Network for Women's and Children's Health Research
Research Triangle Institute International
Other Identifiers
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GN 06
Identifier Type: -
Identifier Source: org_study_id