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Sponsors and Collaborators: |
University of Copenhagen National Institute for Medical Research, Tanzania The Danish Medical Research Council Danish Council for Development Research |
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Information provided by: | University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT00311298 |
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 |
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Tuberculosis HIV Diabetes |
Behavioral: micronutrients Behavioral: energy-protein |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | The Role of Nutritional Support and Diabetes During Treatment of Pulmonary TB: Two Randomized Nutritional Supplementation Trials in Tanzania |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nyagosya Range, MSc, PhD | 255 744 311952 | hn_range@yahoo.co.uk |
Contact: Henrik Friis, MD, PhD | +45 3532 7669 | h.friis@pubhealth.ku.dk |
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 |
Study ID Numbers: | NIMR-UC-2006-01 |
Study First Received: | April 3, 2006 |
Last Updated: | April 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00311298 History of Changes |
Health Authority: | Tanzania: Ministry of Health |
tuberculosis hiv diabetes protein-energy micronutrients |
Bacterial Infections Metabolic Diseases Acquired Immunodeficiency Syndrome Diabetes Mellitus Endocrine System Diseases Trace Elements Gram-Positive Bacterial Infections HIV Infections |
Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis Micronutrients Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Bacterial Infections Metabolic Diseases Growth Substances Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Trace Elements |
Pharmacologic Actions Actinomycetales Infections Gram-Positive Bacterial Infections Mycobacterium Infections Tuberculosis Micronutrients Glucose Metabolism Disorders |