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Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis

NCT01635153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2020-08-18

Study results available
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Summary

The objective of this randomized, controlled trial is to determine if adding a protein-calorie supplement (PCS) to the standard treatments for tuberculosis (TB) and HIV will improve health outcomes. The investigators will enroll 180 HIV-positive women with newly diagnosed active TB and without prior anti-retroviral therapy (ART). At baseline, the investigators will conduct dietary interviews, measure body composition, randomize subjects to receive a PCS (plus micronutritional supplements \[MNS\]) or control (MNS only) for the 6-month duration of anti-TB therapy (ATT) plus an additional 2 mos (8 mos total). Subjects will be followed monthly and have CD4 counts at baseline, 2, 8 and 12 months. At 2 months (i.e., at the end of the 4 drug intensive phase of TB treatment and start of the 2 drug continuation phase), all subjects will be started on anti-retroviral therapy (ART) based on Tanzanian Ministry of Health guidelines (currently: AZT/3TC/efavirenz). The primary endpoint will be change in CD4 count after 8 months (i.e., at end of PCS/MNS intervention and 2 months after completion of ATT).

Conditions

Interventions

DIETARY_SUPPLEMENT

Protein calorie supplement

Fortified porridge with 1062 kcal and 40 gm protein

DIETARY_SUPPLEMENT

Micronutrient

Dar-vite Multivitamin

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Charles F. von Reyn, MD · Dartmouth College

  • Nyasule Majura-Neke, MD · Muhimbili University of Health and Allied Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01635153 on ClinicalTrials.gov