A Phase 3 interventional study of Multimicronutrients and Energy and proteins in Tuberculosis, HIV and Diabetes, sponsored by University of Copenhagen. Completed at 1 site in Tanzania. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2009-08-04.
Sponsored by University of Copenhagen · Phase 3, Interventional, and Treatment
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 1,250 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
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Exclusion Criteria:
Biscuit without additional micronutrients
Dietary Supplement: Multimicronutrients
Biscuit with additional micronutrients
Dietary Supplement: Multimicronutrients
1 biscuit with micronutrients
Dietary Supplement: Energy and proteins
1 biscuit with micronutrients, plus 5 biscuits without additional micronutrients
Dietary Supplement: Energy and proteins
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.
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.
Weight gain
Time frame: 2 and 5 months
Grip strength
Time frame: 2 and 5 months
Arm muscle and arm fat areas
Time frame: 2 and 5 months
Physical activity
Time frame: 2 and 5 months
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
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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University of Copenhagen