Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: a double-blind randomised controlled trial

被引:2
|
作者
Seely, Dugald [1 ,2 ,3 ]
Legacy, Mark [1 ,2 ]
Conte, Ellen [1 ]
Keates, Caitlyn [1 ]
Psihogios, Athanasios [1 ]
Ramsay, Tim [2 ,4 ]
Fergusson, Dean A. [2 ,4 ]
Kanji, Salmaan [2 ,5 ]
Simmons, John-Graydon [2 ,6 ]
Wilson, Kumanan [2 ,6 ,7 ]
机构
[1] Canadian Coll Naturopath Med, Patterson Inst Integrat Oncol Res, Toronto, ON, Canada
[2] Ottawa Hosp Res Inst, Ottawa, ON, Canada
[3] Univ Ottawa, Sch Epidemiol & Publ Hlth, Ottawa, ON, Canada
[4] Univ Ottawa, Sch Epidemiol & Community Med, Ottawa, ON, Canada
[5] Ottawa Hosp, Dept Pharm, Ottawa, ON, Canada
[6] Univ Ottawa, Dept Med, Ottawa, ON, Canada
[7] Bruyere Res Inst, Ottawa, ON, Canada
来源
BMJ OPEN | 2023年 / 13卷 / 09期
关键词
COMPLEMENTARY MEDICINE; COVID-19; Clinical Trial; RESPIRATORY-TRACT INFECTION; COMMON COLD; ZINC;
D O I
10.1136/bmjopen-2023-073761
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BackgroundCOVID-19 has caused morbidity, hospitalisation and mortality worldwide. Despite effective vaccines, there is still a need for effective treatments, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. We sought to evaluate whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc could improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19.MethodsParticipants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 & mu;g) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality.Results90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 on a scale of 0-2100. No clinically or statistically significant differences were seen in any secondary outcomes.InterpretationIn this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility.Trial registration numberNCT04780061.
引用
收藏
页数:9
相关论文
共 50 条
  • [1] Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: study protocol for a randomised, double-blind, placebo controlled clinical trial
    Legacy, Mark
    Seely, Dugald
    Conte, Ellen
    Psihogios, Athanasios
    Ramsay, Tim
    Fergusson, Dean A.
    Kanji, Salmaan
    Simmons, John-Graydon
    Wilson, Kumanan
    BMJ OPEN, 2022, 12 (03): : e057024
  • [2] Double-blind randomised trial of saline solution for gargling and nasal rinsing in SARS-CoV-2 infection
    Espinoza, Sebastian R.
    Trauffler, Lexton
    Shamshirsaz, Amir
    Shamshirsaz, Alireza
    Espinoza, Andres
    Espinoza, Jimmy
    O'Brien, Alice
    JOURNAL OF GLOBAL HEALTH, 2024, 14
  • [3] Cetylpyridinium Chloride Mouthwash to Reduce Shedding of Infectious SARS-CoV-2: A Double-Blind Randomized Clinical Trial
    Alemany, A.
    Perez-Zsolt, D.
    Raich-Regue, D.
    Munoz-Basagoiti, J.
    Ouchi, D.
    Laporte-Villar, C.
    Baro, B.
    Henriquez, N.
    Prat, N.
    Ochoa Gianinetto, M.
    Viaplana Gutierrez, M.
    Garcia Sanchez-Paniagua, M.
    Larrosa Henriquez, N.
    Moreno Vicente, J.
    Ara, J.
    Rodriguez-Arias, M. A.
    Puig, J.
    Blanco, I
    Casan Lopez, C.
    Hernandez, A.
    Bordoy, A. E.
    Esteban Redondo, C.
    Gonzalez Soler, V
    Gimenez, M.
    Blanc, V
    Leon, R.
    Gispert, J.
    Clotet, B.
    Izquierdo-Useros, N.
    Mitja, O.
    JOURNAL OF DENTAL RESEARCH, 2022, 101 (12) : 1450 - 1456
  • [4] Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial
    Chen, Gui-Ling
    Li, Xiao-Feng
    Dai, Xia-Hong
    Li, Nan
    Cheng, Meng-Li
    Huang, Zhen
    Shen, Jian
    Ge, Yu-Hua
    Shen, Zhen-Wei
    Deng, Yong-Qiang
    Yang, Shu-Yuan
    Zhao, Hui
    Zhang, Na-Na
    Zhang, Yi-Fei
    Wei, Ling
    Wu, Kai-Qi
    Zhu, Meng-Fei
    Peng, Cong-Gao
    Jiang, Qi
    Cao, Shou-Chun
    Li, Yu-Hua
    Zhao, Dan-Hua
    Wu, Xiao-Hong
    Ni, Ling
    Shen, Hua-Hao
    Dong, Chen
    Ying, Bo
    Sheng, Guo-Ping
    Qin, Cheng-Feng
    Gao, Hai-Nv
    Li, Lan-Juan
    LANCET MICROBE, 2022, 3 (03): : E193 - E202
  • [5] Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial
    Xia, Shengli
    Zhang, Yuntao
    Wang, Yanxia
    Wang, Hui
    Yang, Yunkai
    Gao, George Fu
    Tan, Wenjie
    Wu, Guizhen
    Xu, Miao
    Lou, Zhiyong
    Huang, Weijin
    Xu, Wenbo
    Huang, Baoying
    Wang, Huijuan
    Wang, Wei
    Zhang, Wei
    Li, Na
    Xie, Zhiqiang
    Ding, Ling
    You, Wangyang
    Zhao, Yuxiu
    Yang, Xuqin
    Liu, Yang
    Wang, Qian
    Huang, Lili
    Yang, Yongli
    Xu, Guangxue
    Luo, Bojian
    Wang, Wenling
    Liu, Peipei
    Guo, Wanshen
    Yang, Xiaoming
    LANCET INFECTIOUS DISEASES, 2021, 21 (01): : 39 - 51
  • [6] Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial
    Ella, Raches
    Vadrevu, Krishna Mohan
    Jogdand, Harsh
    Prasad, Sai
    Reddy, Siddharth
    Sarangi, Vamshi
    Ganneru, Brunda
    Sapkal, Gajanan
    Yadav, Pragya
    Abraham, Priya
    Panda, Samiran
    Gupta, Nivedita
    Reddy, Prabhakar
    Verma, Savita
    Rai, Sanjay Kumar
    Singh, Chandramani
    Redkar, Sagar Vivek
    Gillurkar, Chandra Sekhar
    Kushwaha, Jitendra Singh
    Mohapatra, Satyajit
    Rao, Venkat
    Guleria, Randeep
    Ella, Krishna
    Bhargava, Balram
    LANCET INFECTIOUS DISEASES, 2021, 21 (05): : 637 - 646
  • [7] Predictors of severity of SARS-CoV-2 infections in Brazil: Post hoc analyses of a randomised controlled trial
    Conlin, Kerry
    Jenkin, Daniel
    de Whalley, Philip
    Weckx, Lily Yin
    Folegatti, Pedro M.
    Bibi, Sagida
    Lambe, Teresa
    Aley, Parvinder K.
    Pollard, Andrew J.
    Voysey, Merryn
    Clemens, Sue Ann Costa
    VACCINE, 2025, 45
  • [8] Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial
    Han, Bihua
    Song, Yufei
    Li, Changgui
    Yang, Wanqi
    Ma, Qingxia
    Jiang, Zhiwei
    Li, Minjie
    Lian, Xiaojuan
    Jiao, Wenbin
    Wang, Lei
    Shu, Qun
    Wu, Zhiwei
    Zhao, Yuliang
    Li, Qi
    Gao, Qiang
    LANCET INFECTIOUS DISEASES, 2021, 21 (12): : 1645 - 1653
  • [9] Randomised, double-blind, placebo-controlled, assessment of the efficacy and safety of dietary supplements in prehypertension
    Pelliccia, F.
    Pasceri, V.
    Marazzi, G.
    Arrivi, A.
    Cacciotti, L.
    Pannarale, G.
    Speciale, G.
    Greco, C.
    Gaudio, C.
    JOURNAL OF HUMAN HYPERTENSION, 2017, 31 (10) : 647 - 653
  • [10] Randomised, double-blind, placebo-controlled, assessment of the efficacy and safety of dietary supplements in prehypertension
    F Pelliccia
    V Pasceri
    G Marazzi
    A Arrivi
    L Cacciotti
    G Pannarale
    G Speciale
    C Greco
    C Gaudio
    Journal of Human Hypertension, 2017, 31 : 647 - 653