Improving tuberculosis treatment by high-energy biscuits in Mwanza, Tanzania

Completed

• Conditions: Tuberculosis with and without HIV co-infection; Infections and Infestations; Respiratory tuberculosis, bacteriologically and histologically confirmed

• Registration Number: ISRCTN16552219
• Lead Sponsor: niversity of Copenhagen (Denmark)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Sputum smear positive TB patients
2. > 15 years old

Exclusion Criteria

1. Pregnant women
2. Age < 15 years
3. Non-residency of study area
4. Terminal illness (unlikely to survive > 48 hours)
5. Receiving antiretroviral therapy
6. Not willing to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in TB drug exposure (AUC) during the first two months in the group receiving intervention compared to the group receiving standard care.

Secondary Outcome Measures

Name	Time	Method
1. Improved immune recovery (CD4 increase) and decline in HIV RNA load in the intervention group<br>2. Improved and faster increase in lean body mass and physical strength<br>3. Less reporting of adverse effects