Nutrition, Diabetes and Pulmonary TB/HIV

Phase 3

Completed

• Conditions: Tuberculosis; HIV; Diabetes
• Interventions: Dietary Supplement: Multimicronutrients; Dietary Supplement: Energy and proteins

• Registration Number: NCT00311298
• Lead Sponsor: University of Copenhagen

Brief Summary

We propose a randomised trial among pulmonary TB patients, examined and treated as part of the national TB control programme (WHO, 2003). The aim is to improve TB treatment outcome in high TB and HIV burden countries. The overall objective of the proposed trial is to assess the effect of nutritional support on TB treatment outcomes, and to assess the role of diabetes on risk and severity of TB, and TB treatment outcomes. The study will be conducted in Mwanza Tanzania. All patients will initially be examined for HIV and diabetes. A total of 500 found pulmonary TB smear-positive (PTB+) and HIV positive (HIV+) will be randomised to a daily supplement of 1 versus 6 energy-protein bars throughout treatment, both with full multi-micronutrient (MN) content. A total of 1500 found pulmonary TB smear-negative (PTB-, irrespective of HIV status) and PTB+ and HIV negative (HIV-) will be randomised to 1 daily energy-protein bar containing either low or high MN content.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-05
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-03
• Last Update Posted: 2009-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

• New sputum smear positive or negative pulmonary TB patients

Exclusion Criteria

• pregnant, terminally ill, other serious diseases (except HIV and diabetes), non-residents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No micronutrients	Multimicronutrients	Biscuit without additional micronutrients
Micronutrients	Multimicronutrients	Biscuit with additional micronutrients
1 biscuit	Energy and proteins	1 biscuit with micronutrients
6 biscuits	Energy and proteins	1 biscuit with micronutrients, plus 5 biscuits without additional micronutrients

Primary Outcome Measures

Name	Time	Method
Weight gain	2 and 5 months

Secondary Outcome Measures

Name	Time	Method
CD4 count	2 and 5 months
Serum acute phase reactants	2 months
Mortality	12 month
Grip strength	2 and 5 months
Arm muscle and arm fat areas	2 and 5 months
Physical activity	2 and 5 months
HIV load	2 months

Trial Locations

Locations (1)

Mwanza Medical Centre, NIMR; 🇹🇿 Mwanza, Tanzania