NCT01431482

Brief Summary

This study is an evaluation of the composition of human milk and health outcomes in children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

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

August 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 14, 2023

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

June 7, 2011

Last Update Submit

March 13, 2023

Conditions

Respiratory SymptomsSigns and Symptoms, DigestiveAnemia

Keywords

skin symptoms

Outcome Measures

Primary Outcomes (1)

  • Incidence of infectious and allergic Gastrointestinal events through 2 years of age

    Number of incidences of infectious and allergic Gastrointestinal events for each participant through 2 years of age

    2 years of age

Secondary Outcomes (3)

  • Incidence of infectious and allergic respiratory events through 2 years of age

    2 years of age

  • anthropometric measurements

    2 years of age

  • Incidence of anemia in first 2 years of age

    2 years of age

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children up to 2 years of age

You may qualify if:

  • Human milk samples from mothers from a larger birth co-hort study
  • Health outcomes of children from mothers from a larger birth co-hort study from birth through two years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human milk samples

MeSH Terms

Conditions

Signs and Symptoms, RespiratorySigns and Symptoms, DigestiveAnemia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Hugo Ribeiro, Jr, M.D.

    Federal University of Bahia School of Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2011

First Posted

September 9, 2011

Study Start

August 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 14, 2023

Record last verified: 2013-05