Animal Source Food Supplement and Pregnancy in Vietnam
Condition: Low Birth Weight; Preterm Birth
MeSH terms: Premature Birth; Birth Weight
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a nutrient-rich supplement of animal-source
      foods ingested 5d/wk from pre-conception to term improves maternal nutrient status, decreases
      infections, and improves birth weight and rates of prematurity compared with supplemental
      ingestion during pregnancy ( from mid-gestation to term) or routine prenatal care.
    

Detailed description: 
      It has been known for over 80 years that maternal starvation reduces fetal growth and
      increases neonatal infections. Many different nutrition programs have been targeted to
      pregnant women to improve pregnancy outcomes. The impact of these programs has been
      disappointing, and the prevalence of low birth weight (LBW) and infant mortality remains
      high, especially in developing countries. More recently, as a result of improved access to
      cereals following the 'green revolution,' nutritional concerns shifted from protein and
      energy to micronutrient deficiencies, especially those micronutrients in animal-source foods
      (ASFs)-iron, zinc, vitamins A and B12. Diets of pregnant women are usually limited to rice
      and a few vegetables, and they lack key nutrients known to reduce preterm delivery, to
      support fetal growth, and to prevent infections that leads to early neonatal deaths. Vietnam
      has a well-established farm system that supports the local production of fish, pork, poultry,
      and eggs. This provides an opportunity to evaluate the impact of a food-based,
      micronutrient-rich supplement on pregnancy outcome in high-risk, rural Vietnamese women.
      Since maternal nutritional status at conception is strongly linked to pregnancy outcomes, we
      will compare the effect of consuming a micronutrient-rich, animal-source food (ASF)
      supplement from pre-conception to term with a supplement from mid-gestation to term or
      routine prenatal care on infant birth weight, prematurity rate, and infant growth during the
      first 6 months of life. This study will be the first to compare a food-based,
      micronutrient-rich supplement consumed prior to conception to term with one given only during
      pregnancy. Although it is recognized by many that pregnancy may be too narrow a window to
      improve maternal nutritional health, it is typical for micronutrient supplements to only be
      given from the time of enrolling for prenatal care to term. The results of our study,
      therefore, will have world-wide implications regarding when maternal supplementation should
      be given to have the greatest impact on pregnancy outcome.
    

Intervention name(s): Food
Intervention type(s): Other
Intervention description(s): Animal-source food (ASF) supplement rich in iron, zinc, vitamin A, and vitamin B12 taken week-days at mid-morning separate from other food. Length of intervention is either from pre-pregnancy (time of registration to marry) to term or from 16 weeks gestation to term.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: birth weight; prematurity; gestational age; low birth weight; pregnancy; nutrition; Vietnam