Nutrition, Diabetes and Pulmonary TB/HIV

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV, Tuberculosis, Diabetes

Intervention / Treatment
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* Dietary Supplement: Multimicronutrients
* Dietary Supplement: Energy and proteins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No micronutrients<br>Biscuit without additional micronutrients | Dietary Supplement: Multimicronutrients<br>* 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.<br>|
| Experimental: Micronutrients<br>Biscuit with additional micronutrients | Dietary Supplement: Multimicronutrients<br>* 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.<br>|
| Active Comparator: 1 biscuit<br>1 biscuit with micronutrients | Dietary Supplement: Energy and proteins<br>* 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.<br>|
| Experimental: 6 biscuits<br>1 biscuit with micronutrients, plus 5 biscuits without additional micronutrients | Dietary Supplement: Energy and proteins<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 2 and 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tuberculosis, hiv, diabetes, protein-energy, micronutrients