An interventional study of Food in Low Birth Weight and Preterm Birth, sponsored by UCSF Benioff Children's Hospital Oakland. Completed at 1 site in Vietnam. Open to female participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by UCSF Benioff Children's Hospital Oakland · Not applicable, Interventional, and Prevention
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.
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.
2,557 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 291 is above the median of 84 across 1,691 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12
Other: Food
Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12
Other: Food
Nutrition education and iron-folate supplements during pregnancy
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.
Birth Weight
Weight of baby at birth on a scale weighing to 0.1 g made within one hour of delivery
Time frame: At birth
Preterm birth
Birth of baby prior to 37 weeks gestation based on mother's last menstrual period, confirmed by ultrasound
Time frame: At birth
Plan to share: No
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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UCSF Benioff Children's Hospital Oakland