Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/08/2008
Date assigned
03/12/2008
Last edited
15/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Hoffman

ORCID ID

Contact details

Rutgers
The State University of New Jersey
27 Nichol Avenue
Room 228B
New Brunswick
08901
United States of America

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

http://www.enc-online.org

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

Publication citations

Additional files

Editorial Notes