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

December 16, 2013 updated by: NICHD Global Network for Women's and Children's Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Infant Maize/Zn Supplementation Trial:
Linear growth velocity
Zn Homeostasis Studies:
Measures of zinc homeostasis

Secondary Outcome Measures

Outcome Measure
Weight gain
Infant Maize/Zn Supplementation Trial:
Morbidity
Infant neurodevelopment
Maternal and infant biomarkers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NICHD Global Network for Women's and Children's Health

Collaborators

National Cancer Institute (NCI)
University of Colorado, Denver
National Institute of Dental and Craniofacial Research (NIDCR)
Bill and Melinda Gates Foundation
National Center for Complementary and Integrative Health (NCCIH)
Fogarty International Center of the National Institute of Health
USDA Beltsville Human Nutrition Research Center
RTI International
Global Network for Women's and Children's Health Research
Center for Studies of Sensory Impairment, Aging and Metabolism
Foundation for Alimentation and Nutrition, Central America and Panama

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

December 3, 2004

First Submitted That Met QC Criteria

December 3, 2004

First Posted (Estimate)

December 6, 2004

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GN 06
  • U01HD040657 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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