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Randomized Placebo-Controlled Trial (RPCT) of Maize/Zinc in Guatemala

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ClinicalTrials.gov Identifier: NCT00098202
Recruitment Status : Completed
First Posted : December 6, 2004
Last Update Posted : December 17, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Nutrition Pregnancy Drug: Low phytic acid maize Drug: Zinc Phase 3

Detailed Description:

Poor mineral nutrition, especially deficiencies of iron and zinc, is a major cause of maternal and, especially, infant morbidity/mortality in developing world countries. The objectives of this study are to determine whether: a) linear growth velocity between 6 and 12 months in infants receiving a 5mg Zn supplement will be greater than that for infants receiving placebo; b) linear growth velocity will be greater for infants receiving complementary foods containing low phytate maize than for the infants fed wild-type control maize. In addition, Zn metabolic studies will be performed. The objective of the metabolic studies are to measure key variables of Zn homeostasis in maternal participants during changes in the reproductive cycle and in infants during a time when they are most vulnerable to Zn deficiency.

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomized Placebo-Controlled Trial (RPCT) of Maize/Zinc in Guatemala
Study Start Date : March 2003
Study Completion Date : April 2007
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Infant Maize/Zn Supplementation Trial:
  2. Linear growth velocity
  3. Zn Homeostasis Studies:
  4. Measures of zinc homeostasis

Secondary Outcome Measures :
  1. Infant Maize/Zn Supplementation Trial:
  2. Weight gain
  3. Morbidity
  4. Infant neurodevelopment
  5. Maternal and infant biomarkers

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • 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

Exclusion criteria:

  • Other member of the dwelling unti already enrolled in the study.
  • Mother has more than eight living children.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098202

Comalapa, Guatemala
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
John E. Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
RTI International
University of Colorado, Denver
Center for Studies of Sensory Impairment, Aging and Metabolism
Foundation for Alimentation and Nutrition, Central America and Panama
USDA Beltsville Human Nutrition Research Center
Principal Investigator: Michael Hambidge, MD University of Colorado, Denver
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00098202     History of Changes
Other Study ID Numbers: GN 06
U01HD040657 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2004    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by NICHD Global Network for Women's and Children's Health:
Global Network
Maternal and child health
Women's health

Additional relevant MeSH terms:
Trace Elements
Growth Substances
Physiological Effects of Drugs