Human Milk Profiles and Dietary Intake of Chinese Lactating Mothers During Early Lactation Period in Shanghai

Dumex Baby Food Co., Ltd.1 site in 1 country120 target enrollmentFebruary 2014

ConditionsBreast Milk

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Milk
Sponsor: Dumex Baby Food Co., Ltd.
Enrollment: 120
Locations: 1
Primary Endpoint: Breast milk composition
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to investigate breast milk composition and dietary habits of Chinese lactating mothers. Further understanding of the composition of human milk will help to understand the nutritional needs of mothers and their infants in their early phase of life which eventually will help to support breastfeeding.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

June 2016

Last Updated

11 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Dumex Baby Food Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) whose birth weight is \>10 and \<90 percentiles gestational birth weight chart.
•Aged 20 - 40 years.
•Mothers who intend to exclusively breastfeed the infant for more than 6 weeks.
•Chinese ethnicity, including both parents.
•Mothers who sign the informed consent form in writing.

Exclusion Criteria

•Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
•Difficult to follow up and/or locate (e.g. known transfer to other hospitals, residing outside Shanghai, plan to move out of Shanghai).
•Current smoker or having smoked during the pregnancy.
•Having consumed alcoholic drinks during pregnancy or lactation.
•Illegal drug abuser: cannabinoids (marijuana, hashish), stimulants (cocaine, amphetamine, methamphetamine), opioid (heroin, opium).
•Acute infection disease or neoplastic disease or any kind of weakening or debilitating conditions (no history of positive HBV, HCV or HIV serological test at any time during the pregnancy).
•Use of drug or pharmacologically active substances (e.g. herbal products, traditional medicine) to treat a particular disease or medical condition from the beginning of lactation ( those who consume herbal/traditional medicine for maintaining or improving well-being will still be included).
•Presence of mastitis, fungal infections of the nipple or areola; reactivation of herpes simplex (HSV) or varicella zoster infection in the mammary or thoracic region at the time of enrolment.
•Presence of endocrinology diseases, particularly diabetes mellitus and gestational diabetes.
•Presence of obesity (pre-pregnancy BMI \> 28).