- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01235767
Animal Source Food Supplement and Pregnancy in Vietnam (VACVINA)
November 20, 2020 updated by: UCSF Benioff Children's Hospital Oakland
Effect of Animal Source Food Supplement Prior to and During Pregnancy on Birth Weight and Prematurity in Rural Vietnam
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
291
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hanoi, Vietnam
- National Institute of Nutrition
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ASF supplement pre-pregnancy to term
Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12
|
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
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Birth Weight
Time Frame: At birth
|
Weight of baby at birth on a scale weighing to 0.1 g made within one hour of delivery
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At birth
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preterm birth
Time Frame: At birth
|
Birth of baby prior to 37 weeks gestation based on mother's last menstrual period, confirmed by ultrasound
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At birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
May 1, 2016
Study Completion (ACTUAL)
May 1, 2016
Study Registration Dates
First Submitted
November 4, 2010
First Submitted That Met QC Criteria
November 5, 2010
First Posted (ESTIMATE)
November 7, 2010
Study Record Updates
Last Update Posted (ACTUAL)
November 24, 2020
Last Update Submitted That Met QC Criteria
November 20, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-068
- TRF-01 (OTHER_GRANT: Thrasher Research Fund)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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