Low Birth WeightVACVINANCT01235767
Animal Source Food Supplement and Pregnancy in Vietnam
A study testing Food in people with Low Birth Weight and Preterm Birth, run by UCSF Benioff Children's Hospital Oakland at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Low Birth Weight, Preterm Birth
- What is being tested?
- Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteVietnam
- Study dates
- Jan 2011to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Food
- Keywords
- birth weight, prematurity, gestational age, low birth weight, pregnancy, nutrition, Vietnam
- Medical subject headings
- Premature Birth, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ASF supplement pre-pregnancy to term | Experimental | Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12 Receives: Other: Food |
| ASF Supplement mid-gestation to term | Experimental | Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12 Receives: Other: Food |
| Routine prenatal care | No intervention | Nutrition education and iron-folate supplements during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth Weight
Weight of baby at birth on a scale weighing to 0.1 g made within one hour of delivery
Measured: At birth
Secondary outcomes (1)
Preterm birth
Birth of baby prior to 37 weeks gestation based on mother's last menstrual period, confirmed by ultrasound
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet C King, Ph.D., Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235767
- Sponsor's protocol ID
- 2010-068
- Other IDs
- TRF-01
- Acronym
- VACVINA
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2010
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 32584881Nga 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.
PubMed 32469870
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Animal Source Food Supplement Prior to and During Pregnancy on Birth Weight and Prematurity in Rural Vietnam
- ClinicalTrials.gov ID
- NCT01235767
- Acronym / sponsor ID
- VACVINA / 2010-068
- Conditions
- Low Birth Weight, Preterm Birth
- Keywords
- birth weight, prematurity, gestational age, low birth weight, pregnancy, nutrition, Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASF supplement pre-pregnancy to term | Experimental | Other: FoodSupplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12 |
| ASF Supplement mid-gestation to term | Experimental | Other: FoodSupplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12 |
| Routine prenatal care | No intervention | –Nutrition education and iron-folate supplements during pregnancy |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoodAnimal-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. | Other | ASF Supplement mid-gestation to term, ASF supplement pre-pregnancy to term |
Primary outcome
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
1 secondary outcome
Preterm birth
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Derived from this study: PubMed 32584881Quyen 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.
- Derived from this study: PubMed 32469870Nga 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet C King, Ph.D. principal investigator
UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food in people with Low Birth Weight and Preterm Birth, run by UCSF Benioff Children's Hospital Oakland at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth Weight (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01235767, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.