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
  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
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

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 2 and 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.

  Eligibility

Ages Eligible for Study:   15 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311298

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

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 August 18, 2014