Relationship between maternal egg intake and foetal development

ISRCTN	ISRCTN82952463
DOI	https://doi.org/10.1186/ISRCTN82952463
Secondary identifying numbers	N/A

Submission date: 14/08/2008
Registration date: 03/12/2008
Last edited: 15/12/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daniel Hoffman
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Daily consumption of whole eggs during pregnancy promotes foetal growth and development in children born to low-income women.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Eggs
Primary outcome measure	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 study start date	01/09/2008
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	400
Key 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
Key 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
Date of first enrolment	01/09/2008
Date of final enrolment	01/09/2010

Locations

Countries of recruitment

Brazil
United States of America

Study participating centre

Rutgers, The State University of New Jersey

New Brunswick
08901
United States of America

Sponsor information

Egg Nutrition Center (USA)
Industry

1900 L Street NW Suite 725
Washington, DC
20036
United States of America

Website	http://www.enc-online.org
"ROR"	https://ror.org/00289h314

Funders

Funder type

Industry

Egg Nutrition Center (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan