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Animal Source Food Supplement and Pregnancy in Vietnam (VACVINA)

Primary Purpose

Low Birth Weight, Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Food
Sponsored by
UCSF Benioff Children's Hospital Oakland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Birth Weight focused on measuring birth weight, prematurity, gestational age, low birth weight, pregnancy, nutrition, Vietnam

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • National Institute of Nutrition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

ASF supplement pre-pregnancy to term

ASF Supplement mid-gestation to term

Routine prenatal care

Arm Description

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

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

Nutrition education and iron-folate supplements during pregnancy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 4, 2010
Last Updated
November 20, 2020
Sponsor
UCSF Benioff Children's Hospital Oakland
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1. Study Identification

Unique Protocol Identification Number
NCT01235767
Brief Title
Animal Source Food Supplement and Pregnancy in Vietnam
Acronym
VACVINA
Official Title
Effect of Animal Source Food Supplement Prior to and During Pregnancy on Birth Weight and Prematurity in Rural Vietnam
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Birth Weight, Preterm Birth
Keywords
birth weight, prematurity, gestational age, low birth weight, pregnancy, nutrition, Vietnam

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASF supplement pre-pregnancy to term
Arm Type
Experimental
Arm Description
Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12
Arm Title
ASF Supplement mid-gestation to term
Arm Type
Experimental
Arm Description
Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12
Arm Title
Routine prenatal care
Arm Type
No Intervention
Arm Description
Nutrition education and iron-folate supplements during pregnancy
Intervention Type
Other
Intervention Name(s)
Food
Intervention Description
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.
Primary Outcome Measure Information:
Title
Birth Weight
Description
Weight of baby at birth on a scale weighing to 0.1 g made within one hour of delivery
Time Frame
At birth
Secondary Outcome Measure Information:
Title
Preterm birth
Description
Birth of baby prior to 37 weeks gestation based on mother's last menstrual period, confirmed by ultrasound
Time Frame
At birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet C King, Ph.D.
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Nutrition
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32584881
Citation
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.
Results Reference
derived
PubMed Identifier
32469870
Citation
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.
Results Reference
derived

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Animal Source Food Supplement and Pregnancy in Vietnam

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