Randomized controlled trial of nutritional supplementation in patients with newly diagnosed tuberculosis and wasting. Randomised controlled trial of food supplements in patients with newly diagnosed tuberculosis and wasting. Pilot randomized trial of nutritional supplementation in patients with tuberculosis and HIV-tuberculosis coinfection receiving directly observed short-course chemotherapy for tuberculosis. Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste. The effect of energy-protein supplementation on weight, body composition and handgrip strength among pulmonary tuberculosis HIV-co-infected patients: randomised controlled trial in Mwanza, Tanzania. A trial of the effect of micronutrient supplementation on treatment outcome, T cell counts, morbidity, and mortality in adults with pulmonary tuberculosis. Benefits of nutritional supplementation in free-living, frail, undernourished elderly people: a prospective randomized community trial. The effect of vitamin A and zinc supplementation on treatment outcomes in pulmonary tuberculosis: a randomized controlled trial. Adjunctive micronutrient supplementation for pulmonary tuberculosis.
Nutritional support is often recommended as part of the treatment of tuberculosis, but it has never been properly tested.
                We assessed the effects of early nutritional intervention on lean mass and physical function in patients with tuberculosis and wasting.
                Patients who started antituberculous therapy within the previous 2 wk were randomly assigned to receive standard nutritional counseling (control group) or nutritional counseling to increase their intake through diet and high-energy supplements (nutritional supplement group) for 6 wk. Body composition was measured by dual-energy X-ray absorptiometry, and physical function was assessed by maximum grip strength.
                Patients in the nutritional supplement group (n = 19) had a significantly greater increase in body weight (2.57 +/- 1.78 compared with 0.84 +/- 0.89 kg, P = 0.001), total lean mass (1.17 +/- 0.93 compared with 0.04 +/- 1.26 kg, P = 0.006), and grip strength (2.79 +/- 3.11 compared with -0.65 +/- 4.48 kg, P = 0.016) than did the control subjects (n = 17) at week 6. During subsequent follow-up, the increase in body weight remained greater in the nutritional supplement group, but this increase was due mainly to a greater gain in fat mass in the nutritional supplement group than in the control group.
                Early intervention to increase nutritional intake increases lean mass and physical function. This adjunct to tuberculosis therapy could confer socioeconomic and survival benefits that deserve investigation in large-scale trials. Nutritional intervention after the initial phase of treatment could be less beneficial because it mainly increases fat. Wasting is the cardinal feature of tuberculosis, but not much documentary evidence supporting food supplements exists. This study was done to assess the effects of food supplements on body weight, physical function, quality of life and treatment outcomes in patients with tuberculosis and wasting.
                The study was conducted in 30 Anganwadi centres of 16 villages in the catchment area of Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation and the Gannavaram Directly Observed Treatment Short Course chemotherapy centre from August 2005 to December 2005. A total of 100 patients participated in the study. Patients who were started on anti-tubercular therapy within the previous two weeks were randomly assigned to either the control or the food supplement group. At the end of three months, their body weight was measured and physical function and quality of life were assessed. Treatment outcomes were assessed at the one-year follow-up for both groups.
                Patients who received supplements had a significant increase in body weight (8.6 percent versus 2.6 percent, p-value less than 0.001) and maximum grip strength (p-value less than 0.001), a higher sputum conversion rate (p-value is 0.039), a higher treatment completion rate (p-value is 0.031) and improvements in the quality of life scores.
                Intake of food supplements resulted in a definitive increase in body weight and physical function in our study sample. Improvements can be observed in all areas, including psychologically, physiologically, socially and in the treatment outcomes. 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.
                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.
                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.
                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.
                © 2011 Blackwell Publishing Ltd. To determine the effectiveness of the provision of whole food to enhance completion of treatment for tuberculosis.
                Parallel group randomised controlled trial.
                Three primary care clinics in Dili, Timor-Leste.
                270 adults aged >or=18 with previously untreated newly diagnosed pulmonary tuberculosis.
                Completion of treatment (including cure). Secondary outcomes included adherence to treatment, weight gain, and clearance of sputum smears. Outcomes were assessed remotely, blinded to allocation status. Interventions Participants started standard tuberculosis treatment and were randomly assigned to intervention (nutritious, culturally appropriate daily meal (weeks 1-8) and food package (weeks 9-32) (n=137) or control (nutritional advice, n=133) groups. Randomisation sequence was computer generated with allocation concealment by sequentially numbered, opaque, sealed envelopes.
                Most patients with tuberculosis were poor, malnourished men living close to the clinics; 265/270 (98%) contributed to the analysis. The intervention had no significant beneficial or harmful impact on the outcome of treatment (76% v 78% completion, P=0.7) or adherence (93% for both groups, P=0.7) but did lead to improved weight gain at the end of treatment (10.1% v 7.5% improvement, P=0.04). Itch was more common in the intervention group (21% v 9%, P<0.01). In a subgroup analysis of patients with positive results on sputum smears, there were clinically important improvements in one month sputum clearance (85% v 67%, P=0.13) and completion of treatment (78% v 68%, P=0.3).
                Provision of food did not improve outcomes with tuberculosis treatment in these patients in Timor-Leste. Further studies in different settings and measuring different outcomes are required.
                Clinical Trials NCT0019256. Undernutrition is common among smear-positive pulmonary tuberculosis (PTB+) patients. Micronutrient supplementation may improve treatment outcomes, but it is unclear whether additional energy-protein would be beneficial. The present study aimed to assess the effect of energy-protein supplementation on weight, body composition and handgrip strength against a background of high micronutrient intake during tuberculosis (TB) treatment. A total of 377 PTB+ patients co-infected with HIV were randomly allocated one or six biscuits daily for 60 d during TB treatment. Weight, arm fat area, arm muscle area and handgrip strength were assessed at baseline and 2 and 5 months. There were no effects on any outcome at 2 months, but energy-protein supplementation was associated with a 1·3 (95 % CI - 0·1, 2·8) kg marginally significant gain in handgrip strength at 5 months. However, after 2 months, energy-protein supplementation led to a weight gain of 1·9 (95 % CI 0·1, 3·7) kg among patients with cluster of differentiation 4 (CD4) counts ≥ 350 cells/μl, but not among patients with low CD4 counts ( - 0·2 kg; 95 % CI - 1·3, 0·8, Pinteraction = 0·03). Similarly, at 5 months, energy-protein supplementation led to a 2·3 (95 % CI 0·6, 4·1) kg higher handgrip strength gain among patients with CD4 counts < 350 cells/μl, but not in those with high CD4 counts (Pinteraction = 0·04). In conclusion, energy-protein supplementation to PTB+ HIV-co-infected patients had no overall effects on weight and body composition, but was associated with marginally significant gain in handgrip strength. More research is needed to develop an effective supplement, before it is recommended to TB programmes. Tuberculosis (TB) often coincides with nutritional deficiencies. The effects of micronutrient supplementation on TB treatment outcomes, clinical complications, and mortality are uncertain.
                We conducted a randomized, double-blind, placebo-controlled trial of micronutrients (vitamins A, B complex, C, and E, as well as selenium) in Dar es Salaam, Tanzania. We enrolled 471 human immunodeficiency virus (HIV)-infected and 416 HIV-negative adults with pulmonary TB at the time of initiating chemotherapy and monitored them for a median of 43 months.
                Micronutrients decreased the risk ofTB recurrence by 45% overall (95% confidence interval [CI], 7% to 67%; P = .02) and by 63% in HIV-infected patients (95% CI, 8% to 85%; P = .02). There were no significant effects on mortality overall; however, we noted a marginally significant 64% reduction of deaths in HIV-negative subjects (95% CI, -14% to 88%; P = .08). Supplementation increased CD3+ and CD4+ cell counts and decreased the incidence of extrapulmonary TB and genital ulcers in HIV-negative patients. Micronutrients reduced the incidence of peripheral neuropathy by 57% (95% CI, 41% to 69%; P < .001), irrespective of HIV status. There were no significant effects on weight gain, body composition, anemia, or HIV load.
                Micronutrient supplementation could improve the outcome in patients undergoing TB chemotherapy in Tanzania. To evaluate the impact of nutritional supplementation on nutritional status, muscle strength, perceived health, and functional status in a population of community-living, frail, undernourished elderly people.
                A 16-week intervention study in which subjects were randomized to an experimental or a control group and visited in their home on a monthly basis. Outcome variables were measured at the start and end of the study at subjects' homes by a dietitian blinded to treatment assignment.
                83 elderly people (experimental group: n=42; control group: n=41; mean age=80+/-7 years) receiving community home-care services and at high risk for undernutrition.
                Provision of a nutrient-dense protein-energy liquid supplement and encouragement to improve intake from other foods.
                Anthropometric indexes, handgrip strength, isometric elbow flexion and leg extension strength, lower extremity function, perceived health, and functional status.
                Study groups were compared on an "intention to treat" basis using analysis of variance for repeated measures and unpaired and paired t tests and their nonparametric equivalents where appropriate.
                Total energy intake (1,772 vs 1,440 kcal; P<.001) and weight gain (1.62 vs 0.04 kg; P<.001) were higher in the supplemented group. No significant changes were observed with respect to other anthropometric indexes, muscle strength, or functional variables; however, beneficial effects were observed in emotional role functioning (P<0.01) and number of days spent in bed (P=.04).
                Nutrition intervention is feasible in free-living, frail, undernourished elderly people and results in significant improvement of nutritional status with respect to energy and nutrient intake and weight gain. Weight loss can be stopped and in some cases reversed; however, increased physical activity may also be required to improve health and functional status. Low serum concentrations of vitamin A and zinc are common in tuberculosis and may have an adverse effect on host cell-mediated responses. The role of adjunctive micronutrient supplementation on treatment outcomes is uncertain.
                The objective was to assess the efficacy of vitamin A and zinc supplementation on sputum smear and culture conversion and time to culture detection in adults with sputum smear-positive pulmonary tuberculosis.
                Participants attending a primary care tuberculosis clinic in Cape Town, South Africa, were randomly assigned to receive micronutrients (single dose of 200,000 IU retinyl palmitate plus 15 mg Zn/d for 8 wk) or matching placebo. Sputum was collected weekly for 8 wk for auramine staining and culture on liquid media (BACTEC MGIT 960; Becton Dickinson, Sparks, MD). Performance status, chest radiographs, and anthropometric measures were assessed at baseline and again at 8 wk.
                The participants (n = 154) were randomly assigned to the micronutrient (n = 77) or placebo (n = 77) group. Twenty participants were HIV infected (13%), and 12 participants had an unknown HIV status (8%). No differences in time to smear or culture conversion were observed between the treatment groups by Kaplan-Meier analysis (P = 0.15 and P = 0.38, respectively; log-rank test). Log-logistic regression analysis found no significant group interaction effect in time to culture detection over the 8-wk period (P = 0.32). No significant differences in weight gain (2.3 ± 3.5 compared with 2.2 ± 2.4 kg, P = 0.68) or radiologic resolution were observed between the treatment groups.
                Supplementation with vitamin A and zinc did not affect treatment outcomes in participants with pulmonary tuberculosis at 8 wk. This trial was registered at controlled-trials.com as ISRCTN80852505. To assess the effect of micronutrient supplementation on tuberculosis (TB) patient outcomes.
                The randomized, double-blinded, placebo-controlled study was conducted in pulmonary TB patients undergoing directly observed treatment short course/ tratamiento acortado estrictamente supervisado (TAES/ DOTS) at IMSS in Ciudad Juarez, Chihuahua, Mexico, who were recruited during August 2005-July 2006. Consecutive patients received zinc and vitamin A supplements or matched placebo for four months. Dietary intake, blood zinc and vitamin A, immune response (IFN-gamma,TNF-alpha, and IL-10 mRNA), and sputum smear conversion were measured.
                The proportion of micronutrient compared to placebo group subjects with a negative sputum smear by month 3 was significantly increased (p= 0.03). This occurred subsequent to increased TNF-alpha and IFN-gamma and decreased IL-10 observed at month 2. Micronutrient supplementation appeared to accelerate the beneficial therapeutic effect of chemotherapy.
                The earlier elimination of bacilli from sputum was associated with improved zinc status and Th1 immune response. The therapeutic effect of vitamin A was less evident.
There is insufficient research to know whether routinely providing free food or energy supplements results in better tuberculosis treatment outcomes, or improved quality of life. Further trials, particularly from food insecure settings, should have adequate sample sizes to identify, or exclude, clinically important benefits.
Although blood levels of some vitamins may be low in patients starting treatment for active tuberculosis, there is currently no reliable evidence that routinely supplementing at or above recommended daily amounts has clinical benefits.