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Nutrition, Diabetes and Pulmonary TB/HIV
This study is not yet open for participant recruitment.
Verified by University of Copenhagen, April 2006
First Received: April 3, 2006   No Changes Posted
Sponsors and Collaborators: University of Copenhagen
National Institute for Medical Research, Tanzania
The Danish Medical Research Council
Danish Council for Development Research
Information provided by: University of Copenhagen
ClinicalTrials.gov Identifier: NCT00311298
  Purpose

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
Behavioral: micronutrients
Behavioral: energy-protein
Phase III

MedlinePlus related topics: AIDS Diabetes Dietary Supplements Nutritional Support Tuberculosis
U.S. FDA Resources
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

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Weight gain after 2 and 7 months

Secondary Outcome Measures:
  • body composition
  • grip strength
  • physical activity
  • HIV load
  • CD4 count
  • serum acute phase reactants

Estimated Enrollment: 2000
Study Start Date: April 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311298

Contacts
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

Locations
Tanzania
Mwanza Medical Centre, NIMR
Mwanza, Tanzania
Sponsors and Collaborators
University of Copenhagen
National Institute for Medical Research, Tanzania
The Danish Medical Research Council
Danish Council for Development Research
Investigators
Principal Investigator: Nyagosya Range, MSc, PhD Muhimbili Medical Centre, NIMR
Principal Investigator: Henrik Friis, MD, PhD University of Copenhagen
  More Information

Publications:
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

Keywords provided by University of Copenhagen:
tuberculosis
hiv
diabetes
protein-energy
micronutrients

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009