Clinical trial NCT00311298: Nutrition, Diabetes and Pulmonary TB/HIV
Official title: The Role of Nutritional Support and Diabetes During Treatment of Pulmonary TB: Two Randomized Nutritional Supplementation Trials in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tuberculosis
HIV
Diabetes
Keywords: tuberculosis
hiv
diabetes
protein-energy
micronutrients
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research, Tanzania
name: The Danish Medical Research Council
name: Danish Council for Development Research
First posted: 2006-04-05
Enrollment: 1250
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Weight gain
timeFrame: 2 and 5 months
Secondary outcomes:
measure: Grip strength
timeFrame: 2 and 5 months
measure: Arm muscle and arm fat areas
timeFrame: 2 and 5 months
measure: Physical activity
timeFrame: 2 and 5 months
measure: HIV load
timeFrame: 2 months
measure: CD4 count
timeFrame: 2 and 5 months
measure: Serum acute phase reactants
timeFrame: 2 months
measure: Mortality
timeFrame: 12 month
Other outcomes:
Locations:
city: Mwanza
country: Tanzania
facility: Mwanza Medical Centre, NIMR
Study officials:
affiliation: Muhimbili Medical Centre, NIMR
name: Nyagosya Range, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Henrik Friis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1079/bjn20051684.
citation: 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. doi: 10.1186/1471-2334-12-66.