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Completed

NCT Number: NCT04655820

Maternal and Infant Health and Breast Milk Study in South China

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.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

SunYat-sen University

Guangzhou, Guangdong, 510080, China

About this study

Breast milk contains a variety of nutrients that are beneficial to the early development of infants, such as lipids, Vitamins and so on. At present, the level of these nutrients in milk and infant formula are lower and which are present in a different form from that in breast milk. Therefore, this study was designed to investigate the level of nutrients in breast milk of Chinese mothers and learn about its related factors, as well as exploring the relationships between these nutrients and the early development of infants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. The level of nutrients in breast milk samples

    Time frame: 14 months

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

  2. The level of nutrients in blood samples

    Time frame: 14 months

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

Secondary outcomes

  1. General demographic materials

    Time frame: 14 months

    The general demographic materials of mothers were obtained by questionnaire or medical treatment records

  2. Dietary and lifestyle information

    Time frame: 14 months

    Dietary and lifestyle information of mothers were obtained by Food Frequency Questionnaire and 24-hour meal review questionnaire

  3. Health follow-up

    Time frame: 14 months

    Dietary and health outcome of infants were obtained by questionnaire or medical treatment records

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Dec 7, 2020
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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