Nutrition, Diabetes and Pulmonary TB/HIV

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311298
• Other study ID #: NIMR-UC-2006-01
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2006
• Last updated: August 3, 2009
• Start date: April 2006
• Est. completion date: March 2009

Study information

• Verified date: August 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• HIV
• Tuberculosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Tanzania	Mwanza Medical Centre, NIMR	Mwanza

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	Danish Council for Development Research, National Institute for Medical Research, Tanzania, The Danish Medical Research Council

Country where clinical trial is conducted

Tanzania, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain		2 and 5 months	No
Secondary	Grip strength		2 and 5 months	No
Secondary	Arm muscle and arm fat areas		2 and 5 months	No
Secondary	Physical activity		2 and 5 months	No
Secondary	HIV load		2 months
Secondary	CD4 count		2 and 5 months
Secondary	Serum acute phase reactants		2 months
Secondary	Mortality		12 month

External Links

•   National Institute of Medical Research