Energy dense nutritional supplements improve weight gain among malnourished adults with drug-sensitive pulmonary tuberculosis: An open-label randomized controlled trial in Faridabad, India

Objectives Undernutrition affects nearly half of persons with tuberculosis (PWTB) in India and is a major determinant of poor treatment outcomes and impaired recovery. Randomized evidence on macronutrient supplementation in PWTB remains limited. We evaluated whether an energy-dense nutritional supplement (EDNS) could improve weight gain among undernourished adults with drug-sensitive pulmonary TB. Methods We conducted an open-label, two-arm randomized controlled trial in Faridabad, India (2020-2023). Adults with microbiologically confirmed pulmonary TB and mild to moderate undernutrition (BMI 14-18.5 kg/m²) were randomized to receive either EDNS plus standard dietary advice or standard dietary advice alone. Participants in the intervention arm received two sachets of EDNS daily for up to six months. Primary outcomes were ≥5% weight gain at 2 months and ≥10% at treatment completion. We conducted multivariable logistic regression to assess the impact of EDNS. Results Among 335 participants randomized (171 intervention; 164 control), the intervention group had higher proportions achieving ≥5% weight gain at 2 months (53.9% vs 39.3%; P = 0.015) and ≥10% at six months (55.8% vs 41.0%; P = 0.023). After adjusting for covariates, EDNS improved odds of achieving these outcomes (month 2 adjusted odds ratio [aOR] 2.02 [95% CI: 1.25-3.30]; month 6 aOR 1.89 [95% CI: 1.13-3.18]). Acceptability and adherence were high. Gastrointestinal symptoms were more frequent but did not require treatment modification. Conclusion EDNS significantly improved weight gain among undernourished PWTB and may represent a practical, scalable approach to complement existing food basket and cash transfer strategies to aid nutritional recovery during TB treatment.