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NCT Number: NCT00311298

Nutrition, Diabetes and Pulmonary TB/HIV

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.

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Key information

Conditions

Tuberculosis Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders Gram-Positive Bacterial Infections HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Mycobacterium Infections Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mwanza Medical Centre, NIMR

Mwanza, Mwanza Region, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimicronutrients

Dietary Supplement

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.

Energy and proteins

Dietary Supplement

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.

Primary outcomes

  1. Weight gain

    Time frame: 2 and 5 months

Secondary outcomes

  1. Grip strength

    Time frame: 2 and 5 months

  2. Arm muscle and arm fat areas

    Time frame: 2 and 5 months

  3. Physical activity

    Time frame: 2 and 5 months

  4. HIV load

    Time frame: 2 months

  5. CD4 count

    Time frame: 2 and 5 months

  6. Serum acute phase reactants

    Time frame: 2 months

  7. Mortality

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Danish Council for Development Research
  • National Institute for Medical Research, Tanzania
  • The Danish Medical Research Council

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 5, 2006
Registry last updated
Aug 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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