Animal Source Food Supplement and Pregnancy in Vietnam (VACVINA)
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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 |
- 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
- 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 |
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| Contact: Andrew G Hall, Ph.D. | 1686135846 | aghall@ucdavis.edu |
| Contact: Janet C. King, Ph.D. | 510 4507939 | jking@chori.org |
| Vietnam | |
| National Institute of Nutrition | Recruiting |
| Hanoi, Vietnam | |
| Contact: Andrew G Hall, PhD aghall@ucdavis.edu | |
| Principal Investigator: | Janet C King, Ph.D. | Children's Hospital & Research Center Oakland |
More Information
No publications provided
| Responsible Party: | Janet C. King, Children's Hospital Oakland Research Institute |
| ClinicalTrials.gov Identifier: | NCT01235767 History of Changes |
| Other Study ID Numbers: | 2010-068, TRF-01 |
| Study First Received: | November 4, 2010 |
| Last Updated: | August 15, 2011 |
| 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:
|
Birth Weight Premature Birth Body Weight Signs and Symptoms |
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on May 16, 2013