Nutrition, Diabetes and Pulmonary TB/HIV - Full Text View

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:

MedlinePlus related topics: Diabetes Dietary Supplements HIV/AIDS Nutritional Support Tuberculosis

U.S. FDA Resources

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

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:

Dept Human Nutrition, University of Copenhagen This link exits the ClinicalTrials.gov site

National Institute of Medical Research This link exits the ClinicalTrials.gov site

Publications:

Range N, Changalucha J, Krarup H, Magnussen P, Andersen AB, Friis H. The effect of multi-vitamin/mineral supplementation on mortality during treatment of pulmonary tuberculosis: a randomised two-by-two factorial trial in Mwanza, Tanzania. Br J Nutr. 2006 Apr;95(4):762-70.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Andersen AB, Range NS, Changalucha J, Praygod G, Kidola J, Faurholt-Jepsen D, Krarup H, Grewal HM, Friis H. CD4 lymphocyte dynamics in Tanzanian pulmonary tuberculosis patients with and without HIV co-infection. BMC Infect Dis. 2012 Mar 21;12:66.

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 March 03, 2013