L-Carnitine and Biotin as Adjunctive Therapies in Children with Moderate Persistent Asthma: A Randomized Placebo controlled Study

Background and aim Inflammation and oxidative stress were reported to be closely related to pathogenesis of asthma and airway hyperresponsiveness. Hence, this study investigated the beneficial role of L-carnitine and biotin in controlling asthma in children with moderate persistent asthma. Methods This randomized double blind placebo controlled parallel study enrolled 66 children with moderate persistent asthma, who were randomly assigned to three groups; the placebo group (n = 22) which received standard therapy (160 ug Budesonide + 4.5 ug formoterol inhalation) plus placebo capsules twice daily, L-carnitine group (n = 22) which received the same standard therapy plus L-carnitine 500 mg capsules twice daily and biotin group (n = 22) which received the same standard therapy plus biotin 5 mg capsules twice daily. Patients were assessed at baseline and 3 months after intervention to evaluate the change in the serum levels of tumor necrosis factor-alpha (TNF-α), transforming growth factor-beta1 (TGF-β1) and 8-hydroxy-2' -deoxyguanosine (8-OHdG). Additionally, pulmonary function test (Forced Expiratory Volume in 1 second "FEV ₁ " and Forced Expiratory Volume in 1 second/Forced Vital Capacity Ratio "FEV ₁ /FVC") and the Childhood-Asthma Control Test score (C-ACT) were also assessed. Results Three months after intervention and as compared to the placebo group, both L-carnitine and biotin groups produced a significant decline in TNF-α (P = 0.001; P = 0.008 respectively) and 8-OHdG levels (P = 0.022; P = 0.012 respectively). L-carnitine group demonstrated a significant improvement in FEV ₁ (P = 0.035), FEV ₁ /FVC (P = 0.042) and C-ACT (P = 0.016). After intervention, L-carnitine and biotin groups were statistically similar regarding the assessed parameters. Only biotin group showed a significant decline in TGF-β1 (P = 0.028) as compared to baseline value. Both L-carnitine and biotin supplements were safe. Conclusion Both L-carnitine and biotin supplementations may serve as promising adjuvant therapies to augment the clinical benefits in children with moderate persistent asthma. Clinicaltrials.gov registration number: NCT05632549 (Registration date; November 2022)