Nutrition, Diabetes and Pulmonary TB/HIV

The Role of Nutritional Support and Diabetes During Treatment of Pulmonary TB: Two Randomized Nutritional Supplementation Trials in Tanzania

Sponsors

Lead Sponsor: University of Copenhagen

Collaborator: National Institute for Medical Research, Tanzania
The Danish Medical Research Council
Danish Council for Development Research

Source 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.

Overall Status Completed
Start Date April 2006
Completion Date March 2009
Primary Completion Date March 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Weight gain 2 and 5 months
Secondary Outcome
Measure Time Frame
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
CD4 count 2 and 5 months
Serum acute phase reactants 2 months
Mortality 12 month
Enrollment 1250
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Multimicronutrients

Description: Randomised, double-blind trial among pulmonary TB patients, except those who are found to be sputum positive and HIV positive. Both arms received a daily biscuit weighing 30 g (4.5 g protein, 615 kJ). The biscuit given to the No micronutrient-arm contained no additional micronutrients. The biscuit given to the Micronutrient-arm contained the following micronutrients: vitamin A 5000 IU, vitamin B1 20 mg, vitamin B2 20 mg, vitamin B6 25 mg, vitamin B12 50 microg, folic acid 0.8 mg, niacin 40 mg, vitamin C 200 mg, vitamin E 60 mg, vitamin D3 5 µg / 200 IU, selenium 0.2 mg, copper 5 mg, and zinc 30 mg. The intervention was given for 60 days during initial TB treatment.

Intervention Type: Dietary Supplement

Intervention Name: Energy and proteins

Description: Randomised, single-blind trial among sputum-positive HIV-coinfected pulmonary TB patients. Both arms received a daily for biscuit weighing 30 g (4.5 g protein, 615 kJ), with micronutrients (vitamin A 5000 IU, vitamin B1 20 mg, vitamin B2 20 mg, vitamin B6 25 mg, vitamin B12 50 microg, folic acid 0.8 mg, niacin 40 mg, vitamin C 200 mg, vitamin E 60 mg, vitamin D3 5 µg / 200 IU, selenium 0.2 mg, copper 5 mg, and zinc 30 mg). The experimental arm received an additional 5 biscuits without additional micronutrients. Thus, both arms received the same amount of micronutrients. However, the intervention arm received 3690 kJ and 27 g protein per day, while the control arm received 615 kJ and 4.5 g protein. The intervention was given for 60 days during initial TB treatment.

Eligibility

Criteria:

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

Gender: All

Minimum Age: 15 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Mwanza Medical Centre, NIMR
Location Countries

Tanzania

Verification Date

August 2009

Responsible Party

Name Title: Prof. Henrik Friis

Organization: University of Copenhagen

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: No micronutrients

Type: Placebo Comparator

Description: Biscuit without additional micronutrients

Label: Micronutrients

Type: Experimental

Description: Biscuit with additional micronutrients

Label: 1 biscuit

Type: Active Comparator

Description: 1 biscuit with micronutrients

Label: 6 biscuits

Type: Experimental

Description: 1 biscuit with micronutrients, plus 5 biscuits without additional micronutrients

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov