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Clinical Trials/NCT01235767
NCT01235767CompletedNot Applicable

Effect of Animal Source Food Supplement Prior to and During Pregnancy on Birth Weight and Prematurity in Rural Vietnam

UCSF Benioff Children's Hospital Oakland1 site in 1 country291 target enrollmentStarted: January 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
291
Locations
1
Primary Endpoint
Birth Weight

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Non-pregnant women registering to marry in the Cam Khe District of Phu Tho Province
  • •Nulliparous
  • •Planning to reside in the study site for the next 3 years.

Exclusion Criteria

  • •Have had a previous pregnancy
  • •Have a history of severe infections (HIV, TB) or metabolic disease (diabetes)
  • •BMI <17 kg/m2
  • •Do not reside in study communes
  • •Unable to provide informed consent

Arms & Interventions

ASF supplement pre-pregnancy to term

Experimental

Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12

Intervention: Food (Other)

ASF Supplement mid-gestation to term

Experimental

Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12

Intervention: Food (Other)

Routine prenatal care

No Intervention

Nutrition education and iron-folate supplements during pregnancy

Outcomes

Primary Outcomes

Birth Weight

Time Frame: At birth

Weight of baby at birth on a scale weighing to 0.1 g made within one hour of delivery

Secondary Outcomes

  • Preterm birth(At birth)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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