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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesDaily 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) studiedMaternal nutrition and foetal development
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Eggs
Primary outcome measure1. 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 measures1. Maternal body composition, measured at 3 months of gestation
2. Newborn body composition, measured at birth
Overall study start date01/09/2008
Completion date01/09/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants400
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2008
Date of final enrolment01/09/2010

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan