Randomized Placebo-Controlled Trial (RPCT) of Maize/Zinc in Guatemala
Condition: Nutrition; Pregnancy
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Low phytic acid maize; Zinc
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Global Network; Micronutrients; Zinc; Maternal and child health; Women's health; International; Guatemala; Nutrition; Corn; Maize