Nutrition, Diabetes and Pulmonary TB/HIV

University of Copenhagen

Status and phase: Completed; Phase 3

Conditions: Diabetes; Tuberculosis; HIV

Treatments: Dietary Supplement: Energy and proteins; Dietary Supplement: Multimicronutrients

Study type: Interventional

Funder types: Other

Identifiers

NCT00311298

NIMR-UC-2006-01

Details and patient eligibility

About

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.

Enrollment: 1,250 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,250 participants in 4 patient groups, including a placebo group

No micronutrients

Placebo Comparator group

Description:

Biscuit without additional micronutrients

Treatment:

Dietary Supplement: Multimicronutrients

Micronutrients

Experimental group

Description:

Biscuit with additional micronutrients

Treatment:

Dietary Supplement: Multimicronutrients

1 biscuit

Active Comparator group

Description:

1 biscuit with micronutrients

Treatment:

Dietary Supplement: Energy and proteins

6 biscuits

Experimental group

Description:

1 biscuit with micronutrients, plus 5 biscuits without additional micronutrients

Treatment:

Dietary Supplement: Energy and proteins