NCT01699841

Brief Summary

The purpose of this study is to understand how breast milk may protect infants from infection and promote favorable immunological, growth and development outcomes. By following mothers and their infants, we will evaluate the important interactions between infant immune responses and infectious disease events in relation to breast milk composition and feeding patterns. Our aim is to identify a set of predictive factors corresponding to healthy early infant growth and development in this setting in Northern Tanzania.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2013

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2013

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

October 2, 2012

Last Update Submit

October 30, 2017

Conditions

HIVMalnutritionCryptosporidiosis

Outcome Measures

Primary Outcomes (1)

  • Breast milk composition

    Up to 6 months post-partum

Secondary Outcomes (2)

  • Infant anthropometric measures

    Up to 6 months of age

  • Infant infectious disease events

    Up to 6 months of age

Study Arms (1)

HIV+ and HIV- mothers and their infants

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV+ and HIV- mothers and their infants attending a semi-rural clinic and/or rural dispensaries from birth to 6 months of infant age in north western Tanzania.

You may qualify if:

  • Informed consent provided by mothers, and parental consent on behalf of their infants
  • Confirmed maternal HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative)
  • Stated intention to remain in the clinic catchment area ≥6 months post-partum
  • Singleton birth

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kisesa Health Centre

Kisesa, Tanzania

Location

MeSH Terms

Conditions

MalnutritionCryptosporidiosis

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesIntestinal Diseases, ParasiticParasitic DiseasesInfectionsProtozoan Infections, AnimalParasitic Diseases, AnimalCoccidiosisProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesAnimal Diseases

Study Design

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

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 4, 2012

Study Start

April 1, 2012

Primary Completion

June 15, 2013

Study Completion

June 30, 2013

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

TA(1)