NCT04655820

Brief Summary

The purpose of this study was to investigate the nutrients in breast milk of Chinese mothers and its related factors, as well as exploring the early development of infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

November 1, 2020

Last Update Submit

March 3, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • The level of nutrients in breast milk samples

    The nutrients were detected from breast milk samples of mothers by chemical analysis

    14 months

  • The level of nutrients in blood samples

    The nutrients were detected from blood samples of mothers and infants by chemical analysis

    14 months

Secondary Outcomes (3)

  • General demographic materials

    14 months

  • Dietary and lifestyle information

    14 months

  • Health follow-up

    14 months

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women and breast-feeding mothers of this study were recruited from Clifford Hospital during the perinatal period or lactation period

You may qualify if:

  • age 20-45 years
  • natural delivery, singleton pregnancy
  • healthy term infants（at 37-42 weeks of pregnancy）
  • don't smoke and drink
  • self-evaluation as physical health
  • breastfeeding at least until three months of age
  • Apgar score \> 8
  • sign informed consent

You may not qualify if:

  • suffering from mastitis
  • gestational diabetes, hypertension and other metabolic diseases
  • AIDS, tuberculosis and other acute or chronic infectious diseases
  • severe heart and kidney diseases
  • mental system diseases
  • cancer and other malignant consumptive disease
  • take drugs that affect nutrient metabolism
  • infants with congenital and genetic diseases
  • with lactation contraindications
  • don't agree to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SunYat-sen University

Guangzhou, Guangdong, 510080, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and breast milk samples

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 1, 2020

First Posted

December 7, 2020

Study Start

November 20, 2018

Primary Completion

December 30, 2019

Study Completion

December 30, 2022

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)