Nutrition, Diabetes and Pulmonary TB/HIV
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition | Intervention | Phase |
---|---|---|
Tuberculosis HIV Diabetes |
Dietary Supplement: Multimicronutrients Dietary Supplement: Energy and proteins |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | The Role of Nutritional Support and Diabetes During Treatment of Pulmonary TB: Two Randomized Nutritional Supplementation Trials in Tanzania |
- Weight gain [ Time Frame: 2 and 5 months ] [ Designated as safety issue: No ]
- Grip strength [ Time Frame: 2 and 5 months ] [ Designated as safety issue: No ]
- Arm muscle and arm fat areas [ Time Frame: 2 and 5 months ] [ Designated as safety issue: No ]
- Physical activity [ Time Frame: 2 and 5 months ] [ Designated as safety issue: No ]
- HIV load [ Time Frame: 2 months ]
- CD4 count [ Time Frame: 2 and 5 months ]
- Serum acute phase reactants [ Time Frame: 2 months ]
- Mortality [ Time Frame: 12 month ]
Enrollment: | 1250 |
Study Start Date: | April 2006 |
Study Completion Date: | March 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo Comparator: No micronutrients
Biscuit without additional micronutrients
|
Dietary Supplement: Multimicronutrients
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.
|
Experimental: Micronutrients
Biscuit with additional micronutrients
|
Dietary Supplement: Multimicronutrients
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.
|
Active Comparator: 1 biscuit
1 biscuit with micronutrients
|
Dietary Supplement: Energy and proteins
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.
|
Experimental: 6 biscuits
1 biscuit with micronutrients, plus 5 biscuits without additional micronutrients
|
Dietary Supplement: Energy and proteins
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.
|
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Tanzania | |
Mwanza Medical Centre, NIMR | |
Mwanza, Tanzania |
Principal Investigator: | Nyagosya Range, MSc, PhD | Muhimbili Medical Centre, NIMR |
Principal Investigator: | Henrik Friis, MD, PhD | University of Copenhagen |
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Prof. Henrik Friis, University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT00311298 History of Changes |
Other Study ID Numbers: | NIMR-UC-2006-01 |
Study First Received: | April 3, 2006 |
Last Updated: | August 3, 2009 |
Health Authority: | Tanzania: Ministry of Health |
Keywords provided by University of Copenhagen:
tuberculosis hiv diabetes protein-energy micronutrients |
Additional relevant MeSH terms:
Diabetes Mellitus Tuberculosis Tuberculosis, Pulmonary Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Micronutrients Trace Elements Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 03, 2013