Rakesh Lodha1, Aparna Mukherjee1, Varinder Singh1, Sarman Singh1, Henrik Friis1, Daniel Faurholt-Jepsen1, Shinjini Bhatnagar1, Savita Saini1, Sushil K Kabra1, Harleen M S Grewal1. 1. From the Department of Pediatrics (RL, AM, SB, S Saini, and SKK) and Division of Clinical Microbiology & Molecular Medicine, Laboratory Medicine (S Singh), All India Institute of Medical Sciences, New Delhi, India; the Department of Pediatrics, Kalawati Saran Children Hospital, New Delhi, India (VS); the Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark (HF and DF-J); and the Department of Clinical Science, Infection, University of Bergen, Bergen, Norway (HMSG).
Abstract
BACKGROUND: Micronutrients play an important role in immune function. To our knowledge, there have been no comprehensive studies on the role of micronutrient supplementation in children with tuberculosis. OBJECTIVE: We assessed the effect of micronutrient supplementation in children treated with antituberculosis therapy (ATT). DESIGN: A randomized, double-blind, placebo-controlled trial that used a 2 × 2 factorial design was undertaken at 2 teaching hospitals in Delhi. Children with newly diagnosed intrathoracic tuberculosis were enrolled, and they received ATT together with daily supplementation for 6 mo with either zinc alone, micronutrients without zinc, micronutrients in combination with zinc, or a placebo. Main outcomes were weight gain and an improvement in a chest X-ray (CXR) lesion assessed at 6 mo of treatment. RESULTS: A total of 403 children were enrolled and randomly assigned. A microbiological diagnosis of tuberculosis was confirmed in 179 children (44.4%). The median (95% CI) increase in weight-for-age z score at 6 mo was not significantly different between subjects who received micronutrients [0.75 (0.66, 0.84)] and those who did not receive micronutrients [0.76 (0.67, 0.85)] and between subjects who received zinc [0.76 (0.68, 0.85)] and those who did not receive zinc [0.75 (0.66, 0.83)]. An improvement in CXR was observed in 285 children, but there was no difference between those receiving zinc and no zinc or between those receiving micronutrients and no micronutrients after 6 mo of ATT. However, children who received micronutrients had a faster gain in height over 6 mo than did those who did not receive micronutrients (height-for-age z score Δ = 0.08; P = 0.014). CONCLUSIONS:Micronutrient supplementation did not modify the weight gain or clearance of lesions on CXR in children with intrathoracic tuberculosis. However, micronutrient supplementation during treatment may improve height gain in children with intrathoracic tuberculosis. This trial was registered at clinicaltrials.gov as NCT00801606.
RCT Entities:
BACKGROUND: Micronutrients play an important role in immune function. To our knowledge, there have been no comprehensive studies on the role of micronutrient supplementation in children with tuberculosis. OBJECTIVE: We assessed the effect of micronutrient supplementation in children treated with antituberculosis therapy (ATT). DESIGN: A randomized, double-blind, placebo-controlled trial that used a 2 × 2 factorial design was undertaken at 2 teaching hospitals in Delhi. Children with newly diagnosed intrathoracic tuberculosis were enrolled, and they received ATT together with daily supplementation for 6 mo with either zinc alone, micronutrients without zinc, micronutrients in combination with zinc, or a placebo. Main outcomes were weight gain and an improvement in a chest X-ray (CXR) lesion assessed at 6 mo of treatment. RESULTS: A total of 403 children were enrolled and randomly assigned. A microbiological diagnosis of tuberculosis was confirmed in 179 children (44.4%). The median (95% CI) increase in weight-for-age z score at 6 mo was not significantly different between subjects who received micronutrients [0.75 (0.66, 0.84)] and those who did not receive micronutrients [0.76 (0.67, 0.85)] and between subjects who received zinc [0.76 (0.68, 0.85)] and those who did not receive zinc [0.75 (0.66, 0.83)]. An improvement in CXR was observed in 285 children, but there was no difference between those receiving zinc and no zinc or between those receiving micronutrients and no micronutrients after 6 mo of ATT. However, children who received micronutrients had a faster gain in height over 6 mo than did those who did not receive micronutrients (height-for-age z score Δ = 0.08; P = 0.014). CONCLUSIONS: Micronutrient supplementation did not modify the weight gain or clearance of lesions on CXR in children with intrathoracic tuberculosis. However, micronutrient supplementation during treatment may improve height gain in children with intrathoracic tuberculosis. This trial was registered at clinicaltrials.gov as NCT00801606.
Authors: Synne Jenum; S Dhanasekaran; Rakesh Lodha; Aparna Mukherjee; Deepak Kumar Saini; Sarman Singh; Varinder Singh; Guruprasad Medigeshi; Marielle C Haks; Tom H M Ottenhoff; Timothy Mark Doherty; Sushil K Kabra; Christian Ritz; Harleen M S Grewal Journal: Sci Rep Date: 2016-01-04 Impact factor: 4.379
Authors: D Khandelwal; N Gupta; A Mukherjee; R Lodha; V Singh; H M Grewal; S Bhatnagar; S Singh; S K Kabra Journal: Indian J Med Res Date: 2015-06 Impact factor: 2.375
Authors: Synne Jenum; Rasmus Bakken; S Dhanasekaran; Aparna Mukherjee; Rakesh Lodha; Sarman Singh; Varinder Singh; Marielle C Haks; Tom H M Ottenhoff; S K Kabra; T Mark Doherty; Christian Ritz; Harleen M S Grewal Journal: Sci Rep Date: 2016-12-12 Impact factor: 4.379
Authors: John Espen Gjøen; Synne Jenum; Dhanasekaran Sivakumaran; Aparna Mukherjee; Ragini Macaden; Sushil K Kabra; Rakesh Lodha; Tom H M Ottenhoff; Marielle C Haks; Timothy Mark Doherty; Christian Ritz; Harleen M S Grewal Journal: Sci Rep Date: 2017-07-19 Impact factor: 4.379