Animal Source Food Supplement and Pregnancy in Vietnam (VACVINA)

UCSF Benioff Children's Hospital Oakland

Status: Completed

Conditions: Preterm Birth; Low Birth Weight

Treatments: Other: Food

Study type: Interventional

Funder types: Other

Identifiers

NCT01235767

2010-068

TRF-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 291 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No 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.

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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291 participants in 3 patient groups

ASF supplement pre-pregnancy to term

Experimental group

Description:

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

Treatment:

Other: Food

ASF Supplement mid-gestation to term

Experimental group

Description:

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

Treatment:

Other: Food

Routine prenatal care

No Intervention group

Description:

Nutrition education and iron-folate supplements during pregnancy