Nutrition, Diabetes and Pulmonary TB/HIV

This study has been completed.
Sponsor:
Collaborators:
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
First received: April 3, 2006
Last updated: August 3, 2009
Last verified: August 2009

April 3, 2006
August 3, 2009
April 2006
March 2009   (final data collection date for primary outcome measure)
Weight gain [ Time Frame: 2 and 5 months ] [ Designated as safety issue: No ]
Weight gain after 2 and 7 months
Complete list of historical versions of study NCT00311298 on ClinicalTrials.gov Archive Site
  • 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 ]
  • body composition
  • grip strength
  • physical activity
  • HIV load
  • CD4 count
  • serum acute phase reactants
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Tuberculosis
  • HIV
  • Diabetes
  • 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.
  • 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.
  • Placebo Comparator: No micronutrients
    Biscuit without additional micronutrients
    Intervention: Dietary Supplement: Multimicronutrients
  • Experimental: Micronutrients
    Biscuit with additional micronutrients
    Intervention: Dietary Supplement: Multimicronutrients
  • Active Comparator: 1 biscuit
    1 biscuit with micronutrients
    Intervention: Dietary Supplement: Energy and proteins
  • Experimental: 6 biscuits
    1 biscuit with micronutrients, plus 5 biscuits without additional micronutrients
    Intervention: Dietary Supplement: Energy and proteins

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1250
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00311298
NIMR-UC-2006-01
Not Provided
Prof. Henrik Friis, University of Copenhagen
University of Copenhagen
  • National Institute for Medical Research, Tanzania
  • The Danish Medical Research Council
  • Danish Council for Development Research
Principal Investigator: Nyagosya Range, MSc, PhD Muhimbili Medical Centre, NIMR
Principal Investigator: Henrik Friis, MD, PhD University of Copenhagen
University of Copenhagen
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP