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	Treatment or Intervention	Phase
Nutrition Pregnancy	Drug: Low phytic acid maize  Drug: Zinc	Phase III

Further Study Details: 

Primary Outcomes: TRIAL 1: Maize Consumption; Mean birth weight; TRIAL 2: Infant Supplementation; Linear growth velocity
Secondary Outcomes: TRIAL 1: Maternal obstetric outcomes; Maternal morbidity; Infant infectious disease morbidity; Infant growth and development; Metabolic/biomarker outcomes; TRIAL 2: Infectious disease morbidity; Neurodevelopment measures; Zinc and iron status
Expected Total Enrollment:  600

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: 1) The substitution of a low phytic acid maize for a traditional maize that provides the major daily food staple from preconception until 12 months postpartum will increase mean birth weight and reduce the incidence of iron and/or zinc deficiency-linked maternal, fetal and/or infant morbidity and/or impaired growth; 2) A small zinc supplement administered to infants from ages 6 to 12 months whose major food staple is breast milk will accelerate growth and development and decrease infectious disease morbidity.

This study is a nested, randomized, placebo-controlled trial of 600 maternal (300 test, 300 control)/infant pairs that commences at least 3 months prior to conception and continues until each infant is 1 year of age. The first trial is a longitudinal, masked trial of the public health effects of reduction in high dietary phytic acid in a population that depends on maize for its major food staple. The second trial is a masked trial of the effects of a zinc supplement administered daily to the infants in the principal project (low phytic acid and control families) from 6 to 12 months of age. Measurements include both single and longitudinal data on zinc and iron status/bioavailability, on birth weight and fetal and infant growth and development, and on maternal and infant morbidity, especially that related to infectious disease. The primary outcome for the maize consumption trial is mean birth weight; secondary outcomes include maternal obstetric outcomes; maternal morbidity; infant infectious disease morbidity; infant growth and development; and metabolic/biomarker outcomes. The primary outcome for the infant mineral supplementation trial is infant growth velocity between 6 and 12 months; secondary outcomes include infectious disease morbidity; neurodevelopment measures; and zinc and iron status.

The sample size estimates assume a two-tailed Type I error of 0.05, a power of 80%, 15% drop-out of mothers by time of birth due to non conception or other factors, 15% drop-out of infants by 12 months due to mortality or other factors (a total of 30% attrition rate), and an increase in linear growth rate of 6% in the zinc supplement group as compared with the placebo group, within each maize group.

Ages Eligible for Study:  18 Years   -   40 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion criteria:

• Informed consent of mother
• Mother between the ages of 18 and 40 years
• Successful completion of pregnancy within the previous 3 months.
• Mother typically eats a minimum of 15 homemade tortillas per day.
• Mother resides in a community served by the Compalapa, Chimaltenango, Community Health Center in the Western Highlands of Guatemala

Exclusion criteria:

• Evidence of obstructed labor in previous deliveries.
• Mother or partner is sterile.
• Other member of the dwelling unit already enrolled in study.
• Mother has more than eight living children.

Nancy Moss, Ph.D.       mossn@mail.nih.gov

Guatemala
      Community, Comalapa,  Guatemala; Recruiting

Study chairs or principal investigators

Michael Hambidge, MD,  Principal Investigator,  University of Colorado   

Study ID Numbers:  GN 06; U01 HD040657
Record last reviewed:  December 2004
Last Updated:  December 10, 2004
Record first received:  December 3, 2004
ClinicalTrials.gov Identifier:  NCT00098202
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08