Animal Source Food Supplement and Pregnancy in Vietnam (VACVINA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Hospital & Research Center Oakland
Sponsor:
Information provided by (Responsible Party):
Janet King, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01235767
First received: November 4, 2010
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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 Intervention
Low Birth Weight
Preterm Birth
Other: Food

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Birth Weight [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Weight of baby at birth on a scale weighing to 0.1 g made within one hour of delivery


Secondary Outcome Measures:
  • Preterm birth [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Birth of baby prior to 37 weeks gestation based on mother's last menstrual period, confirmed by ultrasound


Estimated Enrollment: 1044
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235767

Contacts
Contact: Janet C King, Ph.D. 510 4507939 jking@chori.org
Contact: Janet C. King, Ph.D. 510 4507939 jking@chori.org

Locations
Vietnam
National Institute of Nutrition Recruiting
Hanoi, Vietnam
Contact: Andrew G Hall, PhD       aghall@ucdavis.edu   
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Investigators
Principal Investigator: Janet C King, Ph.D. Children's Hospital & Research Center Oakland
  More Information

No publications provided

Responsible Party: Janet King, Senior Scientist, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01235767     History of Changes
Other Study ID Numbers: 2010-068, TRF-01
Study First Received: November 4, 2010
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
birth weight
prematurity
gestational age
low birth weight
pregnancy
nutrition
Vietnam

Additional relevant MeSH terms:
Body Weight
Birth Weight
Premature Birth
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on October 01, 2014