Animal Source Food Supplement and Pregnancy in Vietnam

Preterm Birth Clinical Trial

— VACVINA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235767
• Other study ID #: 2010-068
• Secondary ID: TRF-01
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: May 2016

Study information

• Verified date: November 2020
• Source: UCSF Benioff Children's Hospital Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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:

• Married

• 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

Related Conditions & MeSH terms

• Birth Weight
• Low Birth Weight
• Premature Birth
• Preterm Birth

Intervention

Other:
• Food
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.

Locations

Country	Name	City	State
Vietnam	National Institute of Nutrition	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
UCSF Benioff Children's Hospital Oakland

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth Weight	Weight of baby at birth on a scale weighing to 0.1 g made within one hour of delivery	At birth
Secondary	Preterm birth	Birth of baby prior to 37 weeks gestation based on mother's last menstrual period, confirmed by ultrasound	At birth