|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02596295 |
|
Date of registration:
|
03/11/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet
|
|
Scientific title:
|
Human Milk Sample Collection From Israeli Mothers and Its Analysis and Correlation Between Composition, Demographics and Diet |
|
Date of first enrolment:
|
October 2015 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02596295 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Israel
| | | | | | | |
|
Contacts
|
|
Name:
|
Yael Lifshitz, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Employee |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) Mothers who
intend to breastfeed the infant at least 80% of the daily feeding Mothers who can comply
with the study requirements Mothers who sign the informed consent form in writing and can
read and write Hebrew.
Exclusion Criteria:
- Participation in any other studies involving investigational or marketed products Is
consuming alcoholic drinks and is a drug abuser. Is suffering from chronic disease
Presence of psychosis and severe post-partum depression. Mothers who have given birth
to twins or multiples Mothers who received chemotherapy or isotopes during pregnancy
investigator's uncertainty about the willingness or ability of the mothers to
understand and comply with the protocol requirements.
Infants:
Any congenital abnormality, chromosomal disorder or severe disease which could interfere
with the study conduct and assessment.
Age minimum:
15 Years
Age maximum:
55 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Breast Milk Collection
|
|
Primary Outcome(s)
|
|
Analysis of natural lipids in human breast milk of Israeli's mothers
[Time Frame: 30-60 days after delivery]
|
|
Secondary Outcome(s)
|
|
Maternal diet survey
[Time Frame: 30-60 days after delivery]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|