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A Pilot of a Randomized Control Trial of Melatonin and Vitamin C for Mild-to-Moderate COVID-19

Fogleman et al., The Journal of the American Board of Family Medicine, doi:10.3122/jabfm.2022.04.210529, NCT04530539
Jul 2022  
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Recovery 17% Improvement Relative Risk Melatonin  Fogleman et al.  LATE TREATMENT  DB RCT Is late treatment with melatonin beneficial for COVID-19? Double-blind RCT 66 patients in the USA (October 2020 - June 2021) Improved recovery with melatonin (not stat. sig., p=0.38) Fogleman et al., The J. the American B.., Jul 2022 Favorsmelatonin Favorscontrol 0 0.5 1 1.5 2+
Melatonin for COVID-19
10th treatment shown to reduce risk in December 2020
*, now with p = 0.0000002 from 18 studies.
Lower risk for mortality, ventilation, and recovery.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 77 treatments.
Early terminated low-risk patient RCT with 32 low-dose vitamin C, 32 melatonin, and 34 placebo patients, showing faster resolution of symptoms with melatonin in spline regression analysis, and no significant difference for vitamin C. All patients recovered with no serious outcomes reported. Baseline symptoms scores were higher in the melatonin and vitamin C arms (median 27 and 24 vs. 18 for placebo).
Study covers vitamin C and melatonin.
relative recovery, 17.3% better, RR 0.83, p = 0.38, treatment mean 20.33 (±16.4) n=32, control mean 16.82 (±15.7) n=34, mid-recovery, relative symptom improvement, day 9.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Fogleman et al., 27 Jul 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, mean age 52.0, 7 authors, study period 5 October, 2020 - 21 June, 2021, average treatment delay 6.0 days, trial NCT04530539 (history). Contact:
This PaperMelatoninAll
A Pilot of a Randomized Control Trial of Melatonin and Vitamin C for Mild-to-Moderate COVID-19
MD, FAAFP Corey Fogleman, MD, MSc Donna Cohen, MD Alison Mercier, MD Daniel Farrell, MD Jennifer Rutz, MS Kellie Bresz, MPH Tawnya Vernon
The Journal of the American Board of Family Medicine, doi:10.3122/jabfm.2022.04.210529
This study aimed to help determine the effect of dietary supplements on symptom course and quality of life in patients with mild-to-moderate COVID-19 infection. Design: We modified the Wisconsin Upper Respiratory Symptom Survey (WURSS) to conduct a 3 arm, parallel, randomized, double-blind, placebo-controlled trial, enrolling patients with mild-to-moderate symptoms of COVID-19 infection. Patients took placebo (n = 34), vitamin C 1000 mg (n = 32), or melatonin 10 mg (n = 32) orally for 14 days. Outcomes: Ninety Eight (98 out of 104 recruited; mean age = 52 years) patients completed the study. Outcomes were calculated as differences from baseline scores on each of 2 WURSS-derived surveys and analyzed using a spline regression analysis. Regarding symptom progression, those patients taking placebo and vitamin C progressed at the same rate. When compared with those taking placebo (coefficient = -1.09 (95% confidence interval [CI] = -1.39 to -0.8) the group taking melatonin had a faster resolution of symptoms (coefficient = -0.63 [95% CI -1.02 to -0.21] P = .003). By day 14 all 3 groups had reached plateau. Quality-of-life impact analysis demonstrated that the group taking vitamin C improved at the same rate as the group taking placebo (coefficient = -0.71 (95% CI = -1.11 to -0.3)). The group taking melatonin (coefficient = -1.16 (95% CI = -1.75 to -0.57) P < .005) had a faster improvement in quality-oflife. By day 14 all 3 groups had reached plateau. Conclusion: Vitamin C 1000 mg once daily has no effect on disease progression. Melatonin 10 mg daily may have a statistically significant effect but it is unclear if this represents a clinically significant benefit to those with mild-to-moderate symptoms of COVID-19 infection. Further study is warranted. ( J Am Board Fam Med 2022;35:695-707.
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Late treatment
is less effective
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