NCT01647841

Brief Summary

The purpose of this study is to understand how differences in the nutritional status and concentration of hormones and cytokines associated with cachexia in HIV+ and HIV- pregnant women living in a semi-rural and rural region of northern Tanzania affect fetal growth, pregnancy outcomes and early infant health and development. The study hypothesis is that HIV+ women will have worse nutritional status and a greater degree of cachexia which will negatively impact fetal growth, pregnancy outcomes and early infancy health and development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 27, 2013

Status Verified

September 1, 2013

Enrollment Period

1.2 years

First QC Date

July 18, 2012

Last Update Submit

September 26, 2013

Conditions

HIVPregnancyMalnutritionCachexia

Outcome Measures

Primary Outcomes (1)

  • Maternal cachexia score

    Up to 1 month post-partum

Secondary Outcomes (4)

  • Maternal anthropometric measures

    Up to 1 month post-partum

  • Fetal growth

    Up to 1 month post-partum

  • Pregnancy outcomes

    Up to 1 month post-partum

  • Early infant anthropometrics

    Up to 1 month post-partum

Study Arms (1)

Pregnant women and infants

HIV+ and HIV- pregnant women, HIV-exposed and HIV-unexposed infants, ARV-exposed and ARV-unexposed 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- women and their infants attending a semi-rural clinic and/or rural dispensaries for their antenatal and early infancy care in north western Tanzania

You may qualify if:

  • Informed consent provided by mothers, and parental consent on behalf of their infants
  • Confirmed HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative)
  • Estimated gestational age between 12th and 34th weeks
  • 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

MalnutritionCachexia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesWeight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Joann M. McDermid, PhD, RD

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 24, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

September 27, 2013

Record last verified: 2013-09

Locations

TA(1)