NCT04020640

Brief Summary

Research Aim: We assessed human milk intakes of Thai infants during the first 6 months comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding. Methods: One-hundred and ten apparently healthy Thai lactating mother-infant pairs were followed from birth. Human milk intakes were determined at 6 weeks, 3 and 6 months, using the DTM method. Daily energy and protein intakes were assessed using 3-day non-consecutive 24-hour recalls. Socio-demographic characteristics were collected using a questionnaire. For comparisons among breastfeeding practices, one-way ANOVA with Tukey's post hoc test was used for normally distributed data, or Kruskal-Wallis Test with Mann-Whitney U Test for not normally distributed data.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

July 12, 2019

Last Update Submit

July 12, 2019

Conditions

Breast Feeding

Keywords

human milk intakedose-to-mother deuterium oxideexclusive breastfeedingpredominant breastfeedingpartial breastfeeding

Outcome Measures

Primary Outcomes (1)

  • Human milk intake of Thai breastfed infants during the first 6 months using the dose-to-mother deuterium dilution method

    assessed human milk intakes of Thai infants during the first 6 months comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding

    6 months

Study Arms (3)

Exclusive breastfeeding (EBF)

provision of breast milk only, allowing only receiving oral rehydration salts (ORS), drops and syrups (vitamins, minerals, medicines) as necessary

Other: no intervention

Predominant breastfeeding (PBF)

providing breast milk plus other liquids (water and water-based drinks, fruit juice) and ORS, drops and syrups (vitamins, minerals, medicines)

Other: no intervention

Partial breastfeeding (PartBF)

provision of breast milk plus infant formula or cow milk or other solid/semi-solid complementary foods

Other: no intervention

Interventions

no interventionOTHER

Measure human intake using stable isotope technique

Also known as: Observational study
Exclusive breastfeeding (EBF)Partial breastfeeding (PartBF)Predominant breastfeeding (PBF)

Eligibility Criteria

Age2 Weeks - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The mother-infant pairs were recruited at the Ratchaburi hospital and Health promoting hospital, Health promotion center region 5, both situated in Ratchaburi province, central Thailand.

You may qualify if:

  • Apparently healthy women aged 20-35 year
  • Had pre-pregnancy BMI in the normal range (18.5-25 kg/m2)
  • Planned to breastfeed their baby for at least 6 months
  • Being full term infants (gestational age 37-42 weeks) and singleton
  • Had normal birth weight (2,500 - 4,000 g)
  • Signed written informed consent to participate in the study

You may not qualify if:

  • Infant: preterm; twin; low and high birth weight; congenital diseases
  • Mother: chronic diseases needed to get medicine and treatment; underweight and obesity
  • Mother and baby did not stay together throughout 12 months of infant age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Vogelezang S, Santos S, van der Beek EM, Abrahamse-Berkeveld M, Duijts L, van der Lugt A, Felix JF, Jaddoe VWV. Infant breastfeeding and childhood general, visceral, liver, and pericardial fat measures assessed by magnetic resonance imaging. Am J Clin Nutr. 2018 Oct 1;108(4):722-729. doi: 10.1093/ajcn/nqy137.

    PMID: 30107466BACKGROUND

  • Tongchom W, Pongcharoen T, Judprasong K, Udomkesmalee E, Kriengsinyos W, Winichagoon P. Human Milk Intake of Thai Breastfed Infants During the First 6 Months Using the Dose-to-Mother Deuterium Dilution Method. Food Nutr Bull. 2020 Sep;41(3):343-354. doi: 10.1177/0379572120943092. Epub 2020 Aug 17.

    PMID: 32799695DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva sample

MeSH Terms

Conditions

Breast Feeding

Interventions

Observation

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • WANABHORN TONGCHOM, PhD

    Institute of Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 16, 2019

Study Start

July 4, 2013

Primary Completion

November 22, 2015

Study Completion

November 22, 2016

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share