NCT01235767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

5.3 years

First QC Date

November 4, 2010

Last Update Submit

November 20, 2020

Conditions

Low Birth WeightPreterm Birth

Keywords

birth weightprematuritygestational agelow birth weightpregnancynutritionVietnam

Outcome Measures

Primary Outcomes (1)

  • Birth Weight

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

    At birth

Secondary Outcomes (1)

  • Preterm birth

    At birth

Study Arms (3)

ASF supplement pre-pregnancy to term

EXPERIMENTAL

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

Other: Food

ASF Supplement mid-gestation to term

EXPERIMENTAL

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

Other: Food

Routine prenatal care

NO INTERVENTION

Nutrition education and iron-folate supplements during pregnancy

Interventions

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.

ASF Supplement mid-gestation to termASF supplement pre-pregnancy to term

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Nutrition

Hanoi, Vietnam

Location

Related Publications (2)

  • 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.

    PMID: 32584881DERIVED

  • 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.

    PMID: 32469870DERIVED

MeSH Terms

Conditions

Premature BirthBirth Weight

Interventions

Food

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Janet C King, Ph.D.

    UCSF Benioff Children's Hospital Oakland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 8, 2010

Study Start

January 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)