Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Daily consumption of whole eggs during pregnancy promotes foetal growth and development in children born to low-income women.
Ethics approval
1. Rutgers Human Subjects Investigational Review Board, approved on 20/05/2008
2. State University of Rio de Janeiro Human Subjects Ethics Board, approved in January 2008
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Maternal nutrition and foetal development
Intervention
The participants are allocated to four study arms:
Group 1: Normal dietary intake who never consume eggs (non-random allocation)
Group 2: Normal diet who are instructed not to consume eggs (random allocation)
Group 3: Normal diet who are instructed to eat at least one egg per day (random allocation). They will be provided with vouchers redeemable at local stores for the purchase of eggs only.
Group 4: Control group (non-random allocation). They will be provided with standard dietary counselling for pregnant women.
Total duration of interventions: Three months
Intervention type
Drug
Phase
Not Specified
Drug names
Eggs
Primary outcome measures
1. Foetal growth, measured at 3 months and 6 months of gestation
2. Newborn ponderal index, measured at birth
3. APGAR score, measured at birth
Secondary outcome measures
1. Maternal body composition, measured at 3 months of gestation
2. Newborn body composition, measured at birth
Overall trial start date
01/09/2008
Overall trial end date
01/09/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women between the ages of 18 and 40 years
2. Those who are in their 4th or 5th month of singleton pregnancy
3. Free from chronic diseases (heart disease, cancer, diabetes, hypertension, and other disorders that may influence metabolism and growth)
4. Reside in Duque de Caxias in Rio de Janeiro
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
400
Participant exclusion criteria
1. Women who are beyond their 6th month of pregnancy
2. Pregnant with more than one foetus
3. Current use of tobacco, alcohol or illegal drugs
4. Younger than 18 or older than 40 years of age
Recruitment start date
01/09/2008
Recruitment end date
01/09/2010
Locations
Countries of recruitment
Brazil
Trial participating centre
Rutgers, The State University of New Jersey
New Brunswick
08901
United States of America
Sponsor information
Organisation
Egg Nutrition Center (USA)
Sponsor details
1900 L Street NW Suite 725
Washington
DC
20036
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Egg Nutrition Center (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary