In a recent study published in The Lancet Global Health journal, researchers evaluated the impact of nutritional support in Indian adults with microbiologically confirmed pulmonary tuberculosis. The study aimed to assess the impact of micro- and macronutrient supplementation on tuberculosis treatment success, outcomes, and mortality in the study cohort.
Tuberculosis remains a significant public health concern worldwide. In 2021, around three million people had tuberculosis and 494,000 human immunodeficiency virus (HIV)-negative tuberculosis patients died in India. Early diagnosis, comorbidity management, high-quality care, and thorough assessment are necessary to prevent tuberculosis-linked deaths.
Furthermore, undernutrition is a prevalent tuberculosis comorbidity in countries like India with high tuberculosis burden. Undernourished active tuberculosis patients are at risk of drug toxicity, disease relapse, and tuberculosis-associated mortalities.
Although World Health Organization (WHO) advises nutritional counseling, support, and assessment for tuberculosis, these guidelines are not always followed. While research has indicated that undernutrition management may lower tuberculosis mortality, there are conflicting results regarding the effects of micronutrient and macronutrient supplementation during tuberculosis treatment.
About the study
In the present study, the investigators determined how nutritional support impacts tuberculosis treatment efficacy, tuberculosis-linked mortality, and other outcomes across the reducing activation of tuberculosis through the improvement of nutritional status (RATIONS) patient group over a six-month intervention period.
RATIONS is a cluster-randomized, field-based controlled trial analyzing the impact of nutritional support among household contacts of adult microbiologically confirmed pulmonary tuberculosis patients in Jharkhand, India.
Patients aged 18 years or older from 28 tuberculosis units of the National tuberculosis elimination program (NTEP) were enrolled in the study. The present trial was embedded within the NTEP in four districts of Jharkhand: West Singhbhum, Saraikela-Kharsawan, Ranchi, and East Singhbhum.
Household contacts of the tuberculosis patients were eligible for the trial if they resided with the index patient, shared the same kitchen, and did not have an active tuberculosis diagnosis.
Both subject populations in RATIONS, i.e., tuberculosis patients and their household contacts, received nutritional support in the form of micronutrient pills and food rations, i.e., 52 g of protein and 1200 kcal per day.
The patients were nutritionally supported for six months in case of drug-susceptible tuberculosis and 12 months in case of multidrug-resistant tuberculosis. Moreover, drug-susceptible tuberculosis patients were eligible for a six-month extension in nutrition support if they had a body mass index (BMI) below 18.5 kg/m2 at treatment completion.
The team recorded baseline diabetes status, modified Eastern cooperative oncology group (ECOG) performance status, and BMI. Subsequently, weight gain and clinical outcomes such as tuberculosis mortality, treatment success, alteration in performance status, and loss to follow-up were documented at six months.
Tuberculosis mortality predictors were evaluated leveraging Poisson and Cox regression employing adjusted hazard ratios (HRs) and adjusted incidence rate ratios (IRRs).
The research team noted that 2,800 tuberculosis patients, including 1,979 males (70.7%) and 821 females (29.3%), with a mean age of 37.3 years for females and 41.5 years for males, were enrolled in the study between 16 August 2019 and 31 January 2021.
Most participants were from indigenous communities, known as scheduled tribes, engaged in physical labor, and received subsidized food rations from the public distribution system. Around 40% of the participants did not have formal education. Of 2,264 tested participants, 6 (0.3%), had tuberculosis-HIV co-infection, and of the total 2800 participants, 139 (5%), had diabetes.
Further, 2,291 (82.4%), participants had a BMI less than 18.5 kg/m2 and hence were underweight, and the BMI of 480 (17.3% ) participants were below 14 kg/m2 during enrolment. Mean BMI and weight were 16.4 kg/m2 and 42.6 kg for men and 16.2 kg/m2 and 36.1 kg for women, respectively.
In addition, of the 2676 participants, 54% or 1444 patients, demonstrated weight gain of around 5% of their baseline weight at two months. An association was found between decreased tuberculosis-linked mortality and relative and absolute weight gain during the initial two months across the Cox regression analysis.
Tuberculosis mortality predictors included BMI, baseline weight, hemoglobin, diabetes, and poor performance status. A 5% weight gain during the two months was associated with a reduced mortality risk.
At the six-month follow-up, five patients experienced treatment failure, 28 patients were lost to follow-up, 108 participants died due to tuberculosis, and 2,623 participants achieved treatment success. There was a median weight gain of 4.6 kg; however, 1,441 (54.8%) of 2,630 participants remained underweight.
The study results showed that undernutrition was a serious, potentially lethal, and widely prevalent comorbidity among Indian pulmonary tuberculosis patients. While the study reported that baseline body weight was a tuberculosis mortality risk factor, they also noted that weight gain with nutritional support during the initial two months was related to a considerably lowered mortality risk during treatment.
The findings indicated that the nutritional support strategy through micronutrients and food baskets was a practical solution that was linked to performance status normalization, higher treatment success rates, lower loss to follow-up, and improved weight gain in most tuberculosis patients, compared to the NTEP data.
The researchers suggest that tuberculosis programs in India and other nations with high undernutrition and tuberculosis rates should routinely evaluate hemoglobin levels, performance status, and nutritional status during tuberculosis diagnosis, offer graded nutritional support, and provide close supervision and inpatient care referrals during the intensive phase of the illness.