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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02095613
Other study ID # 2008P002017/BWH
Secondary ID R01HD057627
Status Completed
Phase N/A
First received March 20, 2014
Last updated August 10, 2016
Start date May 2010
Est. completion date July 2016

Study information

Verified date August 2016
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardHaiti: Ministry for Public Health and Population
Study type Interventional

Clinical Trial Summary

The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life outcomes when compared to a second type of food supplement (corn-soy-blend) over the course of 12 months of food supplementation.


Recruitment information / eligibility

Status Completed
Enrollment 623
Est. completion date July 2016
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- documented to have HIV infection by standard laboratory procedures

- live in the geographic catchment area of PIH services where study is taking place

- 18 years of age or older

- started antiretroviral therapy for HIV in the 24 months prior to study enrollment

Exclusion Criteria:

- if another household member is also eligible for food assistance

- if subject is pregnant at the time of enrollment

- if unable to give informed consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
traditional food

food that is nutrient dense


Locations

Country Name City State
Haiti Zanmi Lasante Marc

Sponsors (4)

Lead Sponsor Collaborator
Brigham and Women's Hospital Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Harvard Medical School, Partners in Health

Country where clinical trial is conducted

Haiti, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in CD4 cell count over time 6-month, 12-month No
Primary Change in Body Mass Index over time 6-month, 12-month No
Secondary Change in Quality of Life over time 6-month, 12-month No
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