Nutrition, Diabetes and Pulmonary TB/HIV

PHASE3CompletedINTERVENTIONAL
Enrollment

1,250

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions
TuberculosisHIVDiabetes
Interventions
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.

Trial Locations (1)

Unknown

Mwanza Medical Centre, NIMR, Mwanza

All Listed Sponsors
collaborator

National Institute for Medical Research, Tanzania

OTHER_GOV

collaborator

The Danish Medical Research Council

OTHER

collaborator

Danish Council for Development Research

OTHER

lead

University of Copenhagen

OTHER

NCT00311298 - Nutrition, Diabetes and Pulmonary TB/HIV | Biotech Hunter | Biotech Hunter