VACVINA: Animal Source Food Supplement and Pregnancy in Vietnam

Sponsor

UCSF Benioff Children's Hospital Oakland (Other)

Overall Status

Completed

CT.gov ID

NCT01235767

Collaborator

(none)

291

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Birth Weight Preterm Birth	Other: Food	N/A

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

Actual Enrollment :

291 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASF supplement pre-pregnancy to term Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12	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.
Experimental: ASF Supplement mid-gestation to term Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12	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.
No Intervention: Routine prenatal care Nutrition education and iron-folate supplements during pregnancy

Arm

Intervention/Treatment

Experimental: ASF supplement pre-pregnancy to term

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

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.

Experimental: ASF Supplement mid-gestation to term

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

Other: Food

No Intervention: Routine prenatal care

Nutrition education and iron-folate supplements during pregnancy

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Preterm birth [At birth]
Birth of baby prior to 37 weeks gestation based on mother's last menstrual period, confirmed by ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.