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Establishment of the Breast Milk Database in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675204
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Heilongjiang Feihe Dairy Co. Ltd.

Tracking Information
First Submitted Date September 5, 2018
First Posted Date September 18, 2018
Last Update Posted Date July 31, 2019
Actual Study Start Date October 19, 2016
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 16, 2018)
Protein in breast milk [ Time Frame: At enrollment ]
Protein in breast milk measured in percent (%)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 16, 2018)
  • Osmotic pressure [ Time Frame: At enrollment ]
    Osmotic pressure (mmolOsm/Lkg.H2O) in breast milk
  • Fatty acids in breast milk [ Time Frame: At enrollment ]
    Fatty acids composition (mg/L) in breast milk
  • Amino acids [ Time Frame: At enrollment ]
    Amino acids composition (mg/L) in breast milk
  • Oligosaccharides [ Time Frame: At enrollment ]
    Oligosaccharides levels (mg/L) in breast milk
  • Probiotics [ Time Frame: At enrollment ]
    Probiotics composition (species) measured using gene sequencing in breast milk;
  • Vitamins [ Time Frame: At enrollment ]
    Vitamins composition (μg/L) in breast milk
  • Minerals [ Time Frame: At enrollment ]
    Minerals composition (mg/L) in breast milk
  • Hormones [ Time Frame: At enrollment ]
    Hormones composition (mg/L) in breast milk
  • Dietary composition of participating mothers [ Time Frame: At enrollment ]
    Investigation on the dietary composition of participating mothers obtained using questionnaire
  • Height of participating mothers [ Time Frame: At enrollment ]
    Height measurement (cm) of participating mothers
  • Weight of participating mothers [ Time Frame: At enrollment ]
    Body weight measurement (kg) of participating mothers
  • Age of participating mothers [ Time Frame: At enrollment ]
    Age (years) of participating mothers obtained using questionnaire
  • Educational level of participating mothers [ Time Frame: At enrollment ]
    Educational level of participating mothers obtained using questionnaire
  • Occupation of participating mothers [ Time Frame: At enrollment ]
    Occupation of participating mothers obtained using questionnaire
  • Physical health condition of participating mothers [ Time Frame: At enrollment ]
    Physical health condition of participating mothers assessed by questionnaire
  • Triglyceride [ Time Frame: At enrollment ]
    Triglyceride (mg/g) contents in breast milk
  • Phospholipid [ Time Frame: At enrollment ]
    Phospholipid (mg/g) contents in breast milk
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Establishment of the Breast Milk Database in China
Official Title Establishment of the Breast Milk Database in China
Brief Summary Collect breast milk samples in various administrative regions of China to measure the nutrients in breast milk; analyze the composition of nutrients; and establish the database of breast milk in China.
Detailed Description

The study cities are Guangzhou, Weihai, Chengdu, Beijing, Harbin, Wuhan, Jinhua, Zhengzhou and Lanzhou.

Breast milk will be collected at 9:00-11:00 in the morning from 15 to180 days after giving birth. The nutrients (protein, triglyceride, phospholipid, oligosaccharides and probiotics) in the collected breast milk samples will be measured. These data will be used to establish the breast milk database in China. This databased will provide references for infant nutrient intake and for the formulation and revision of infant formula standards. It will also provide references for the development of new infant formula products in China.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
A minimum of 60ml of breast milk will be collected for each subject.
Sampling Method Non-Probability Sample
Study Population Healthy lactating mother of 25 ~ 35 years old who are currently breast-feeding infants of 15 ~180 days old. Subjects are equally distributed in the postpartum time period of 15~35 days, 36~65 days, 66~95 days, 96~125 days, 126~55 days and 156~185 days
Condition Breast Milk Collection
Intervention Other: No intervention
No intervention
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 16, 2018)
1800
Original Actual Enrollment Same as current
Actual Study Completion Date December 30, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Lactating mother 25 ~ 35 years old;
  • Breast-feeding infants (15 ~180 days old );
  • Physically healthy by self-evaluation;
  • Does not smoke;
  • Does not drink alcohol;
  • Have given birth to physically healthy infants;
  • Signed the informed consent forms.

Exclusion Criteria:

  • Being treated for gastrointestinal symptoms;
  • Suffering from mastitis;
  • Suffering from infectious diseases (tuberculosis, viral hepatitis and HIV infection);
  • Suffering from cardiovascular disease;
  • Suffering from metabolic diseases (such as diabetes);
  • Suffering from mental system diseases;
  • Suffering from cancer and other malignant diseases;
  • Having history of taking antibiotics;
  • Not able to answer the study questions;
  • Participating in any nutritional or pharmaceutical intervention study recently.
Sex/Gender
Sexes Eligible for Study: Female
Ages 25 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03675204
Other Study ID Numbers 16-SC-05-FC-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Heilongjiang Feihe Dairy Co. Ltd.
Study Sponsor Heilongjiang Feihe Dairy Co. Ltd.
Collaborators Not Provided
Investigators
Study Director: Shilong Jiang Heilongjiang Feihe Dairy Co. Ltd.
PRS Account Heilongjiang Feihe Dairy Co. Ltd.
Verification Date September 2018