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Randomized Controlled Trial
. 2011 Jun;16(6):699-706.
doi: 10.1111/j.1365-3156.2011.02761.x. Epub 2011 Mar 21.

Pilot randomized trial of nutritional supplementation in patients with tuberculosis and HIV-tuberculosis coinfection receiving directly observed short-course chemotherapy for tuberculosis

T D Sudarsanam  1 , J John, G Kang, V Mahendri, J Gerrior, M Franciosa, S Gopal, K R John, C A Wanke, J Muliyil
Affiliations
Randomized Controlled Trial

Pilot randomized trial of nutritional supplementation in patients with tuberculosis and HIV-tuberculosis coinfection receiving directly observed short-course chemotherapy for tuberculosis

T D Sudarsanam et al. Trop Med Int Health. 2011 Jun.

Abstract

Objective: To investigate the effects of nutritional supplementation on the outcome and nutritional status of south Indian patients with tuberculosis (TB) with and without human immunodeficiency virus (HIV) coinfection on anti-tuberculous therapy.

Method: Randomized controlled trial on the effect of a locally prepared cereal-lentil mixture providing 930 kcal and a multivitamin micronutrient supplement during anti-tuberculous therapy in 81 newly diagnosed TB alone and 22 TB-HIV-coinfected patients, among whom 51 received and 52 did not receive the supplement. The primary outcome evaluated at completion of TB therapy was outcome of TB treatment, as classified by the national programme. Secondary outcomes were body composition, compliance and condition on follow-up 1 year after cessation of TB therapy and supplementation.

Results: There was no significant difference in TB outcomes at the end of treatment, but HIV-TB coinfected individuals had four times greater odds of poor outcome than those with TB alone. Among patients with TB, 1/35 (2.9%) supplemented and 5/42(12%) of those not supplemented had poor outcomes, while among TB-HIV-coinfected individuals, 4/13 (31%) supplemented and 3/7 (42.8%) non-supplemented patients had poor outcomes at the end of treatment, and the differences were more marked after 1 year of follow-up. Although there was some trend of benefit for both TB alone and TB-HIV coinfection, the results were not statistically significant at the end of TB treatment, possibly because of limited sample size.

Conclusion: Nutritional supplements in patients are a potentially feasible, low-cost intervention, which could impact patients with TB and TB-HIV. The public health importance of these diseases in resource-limited settings suggests the need for large, multi-centre randomized control trials on nutritional supplementation.

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Figures

Figure 1
Figure 1
Trial design for the open-labelled randomized trial of macronutrient and micronutrient supplementation during anti-tuberculous therapy in patients with tuberculosis or tuberculosis and HIV.
Figure 2
Figure 2
Mean weight and lean body mass in patients with tuberculosis (TB) and TB–HIV who did and did not receive supplementation during 6 months of anti-tuberculous chemotherapy. Patients were assessed at 0, 2, 4, 5 and 6 months. HIV-coinfected individuals were treated for TB, but did not receive antiretroviral therapy, as per protocol in India at the time.
See this image and copyright information in PMC

References

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