Animal Source Food Supplement and Pregnancy in Vietnam

NCT ID: NCT01235767

Last Updated: 2020-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-05-31

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.

Conditions

Low Birth Weight; Preterm Birth

Keywords

birth weight; prematurity; gestational age; low birth weight; pregnancy; nutrition; Vietnam

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ASF supplement pre-pregnancy to term

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

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

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.

ASF Supplement mid-gestation to term

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

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

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.

Routine prenatal care

Nutrition education and iron-folate supplements during pregnancy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janet C King, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UCSF Benioff Children's Hospital Oakland

Locations

National Institute of Nutrition

Hanoi, , Vietnam

Countries

United States; Vietnam

References

Quyen PN, Nga HT, Chaffee B, Ngu T, King JC. Effect of maternal prenatal food supplementation, gestational weight gain, and breast-feeding on infant growth during the first 24 months of life in rural Vietnam. PLoS One. 2020 Jun 25;15(6):e0233671. doi: 10.1371/journal.pone.0233671. eCollection 2020.

Reference Type: DERIVED

PMID: 32584881 (View on PubMed)

Nga HT, Quyen PN, Chaffee BW, Diep Anh NT, Ngu T, King JC. Effect of a nutrient-rich, food-based supplement given to rural Vietnamese mothers prior to and/or during pregnancy on birth outcomes: A randomized controlled trial. PLoS One. 2020 May 29;15(5):e0232197. doi: 10.1371/journal.pone.0232197. eCollection 2020.

Reference Type: DERIVED

PMID: 32469870 (View on PubMed)

Other Identifiers

TRF-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2010-068

Identifier Type: -

Identifier Source: org_study_id