Relationship between maternal egg intake and foetal development
| ISRCTN | ISRCTN82952463 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82952463 |
| Protocol serial number | N/A |
| Sponsor | Egg Nutrition Center (USA) |
| Funder | Egg Nutrition Center (USA) |
- 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
Scientific
Rutgers, The State University of New Jersey
27 Nichol Avenue
Room 228B
New Brunswick
08901
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Eggs |
| Primary outcome measure(s) |
1. Foetal growth, measured at 3 months and 6 months of gestation |
| Key secondary outcome measure(s) |
1. Maternal body composition, measured at 3 months of gestation |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
08901
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
