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
  • [41] Bisphosphonates in the treatment of Charcot neuroarthropathy: a double-blind randomised controlled trial
    Jude, EB
    Selby, PL
    Burgess, J
    Lilleystone, P
    Mawer, EB
    Page, SR
    Donohoe, M
    Foster, AVM
    Edmonds, ME
    Boulton, AJM
    DIABETOLOGIA, 2001, 44 (11) : 2032 - 2037
  • [42] Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial (vol 21, pg 637, 2021)
    Ella, R.
    Vadrevu, K. M.
    Jogdand, H.
    LANCET INFECTIOUS DISEASES, 2023, 23 (03): : E80 - E80
  • [43] Immunogenicity and Safety of a 3-Dose Regimen of a SARS-CoV-2 Inactivated Vaccine in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
    Liu, Jiankai
    Huang, Baoying
    Li, Guifan
    Chang, Xianyun
    Liu, Yafei
    Chu, Kai
    Hu, Jialei
    Deng, Yao
    Zhu, Dandan
    Wu, Jingliang
    Zhang, Li
    Wang, Meng
    Huang, Weijin
    Pan, Hongxing
    Tan, Wenjie
    JOURNAL OF INFECTIOUS DISEASES, 2022, 225 (10): : 1701 - 1709
  • [44] A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults
    Luo, Deyan
    Pan, Hongxing
    He, Peng
    Yang, Xiaolan
    Li, Tao
    Ning, Nianzhi
    Fang, Xin
    Yu, Wenjing
    Wei, Mingwei
    Gao, Hui
    Wang, Xin
    Gu, Hongjing
    Mei, Maodong
    Li, Xinwang
    Zhang, Liangyan
    Li, Deyu
    Gao, Chunrun
    Gao, Jinbang
    Fei, Guoqiang
    Li, Ying
    Yang, Yuguo
    Xu, Yi
    Wei, Wenjin
    Sun, Yansong
    Zhu, Fengcai
    Hu, Zhongyu
    Wang, Hui
    CLINICAL AND TRANSLATIONAL MEDICINE, 2022, 12 (09):
  • [45] Safety and immunogenicity of Nanocovax, a SARS- CoV-2 recombinant spike protein vaccine: Interim results of a double-blind, randomised controlled phase 1 and 2 trial
    Nguyen, Thuy P.
    Do, Quyet
    Phan, Lan T.
    Dinh, Duc V.
    Khong, Hiep
    Hoang, Luong V.
    Nguyen, Thuong V.
    Pham, Hung N.
    Chu, MenV.
    Nguyen, Toan T.
    Pham, Quang D.
    Le, Tri M.
    Trang, Tuyen N. T.
    Dinh, Thanh T.
    Vo, Thuong V.
    Vu, Thao T.
    Nguyen, Quynh B. P.
    Phan, Vuong T.
    Nguyen, Luong V.
    Nguyen, Giang T.
    Tran, Phong M.
    Nghiem, Thuan D.
    Tran, Tien V.
    Nguyen, Tien G.
    Tran, Tuynh Q.
    Nguyen, Linh T.
    Do, Anh T.
    Nguyen, Dung D.
    Ho, Son A.
    Nguyen, Viet T.
    Pham, Dung T.
    Tran, Hieu B.
    Vu, Son T.
    Hoang, Su X.
    Do, Trung M.
    Nguyen, Xuan T.
    Le, Giang Q.
    Tran, Ton
    Cao, Thang M.
    Dao, Huy M.
    Nguyen, Thao T. T.
    Doan, Uyen Y.
    Le, Vy T. T.
    Tran, Linh P.
    Nguyen, Ngoc M.
    Nguyen, Ngoc T.
    Pham, Hang T. T.
    Nguyen, Quan H.
    Nguyen, Hieu T.
    Nguyen, Hang L. K.
    LANCET REGIONAL HEALTH-WESTERN PACIFIC, 2022, 24
  • [46] Effect of melatonin on duration of delirium in organophosphorus compound poisoning patients: A double-blind randomised placebo controlled trial
    Vijayakumar, H. N.
    Ramya, K.
    Duggappa, Devika Rani
    Gowda, K. M. Veeranna
    Sudheesh, K.
    Nethra, S. S.
    Rao, R. S. Raghavendra
    INDIAN JOURNAL OF ANAESTHESIA, 2016, 60 (11) : 814 - 820
  • [47] Effects of antenatal multiple micronutrient supplementation on birthweight and gestational duration in Nepal: double-blind, randomised controlled trial
    Osrin, D
    Vaidya, A
    Shrestha, Y
    Baniya, RB
    Manandhar, DS
    Adhikari, RK
    Filteau, S
    Tomkins, A
    Costello, AMD
    LANCET, 2005, 365 (9463): : 955 - 962
  • [48] Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial
    Zhang, Yanjun
    Zeng, Gang
    Pan, Hongxing
    Li, Changgui
    Hu, Yaling
    Chu, Kai
    Han, Weixiao
    Chen, Zhen
    Tang, Rong
    Yin, Weidong
    Chen, Xin
    Hu, Yuansheng
    Liu, Xiaoyong
    Jiang, Congbing
    Li, Jingxin
    Yang, Minnan
    Song, Yan
    Wang, Xiangxi
    Gao, Qiang
    Zhu, Fengcai
    LANCET INFECTIOUS DISEASES, 2021, 21 (02): : 181 - 192
  • [49] Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial
    Wu, Zhiwei
    Hu, Yaling
    Xu, Miao
    Chen, Zhen
    Yang, Wanqi
    Jiang, Zhiwei
    Li, Minjie
    Jin, Hui
    Cui, Guoliang
    Chen, Panpan
    Wang, Lei
    Zhao, Guoqing
    Ding, Yuzhu
    Zhao, Yuliang
    Yin, Weidong
    LANCET INFECTIOUS DISEASES, 2021, 21 (06): : 803 - 812
  • [50] Dietary supplements for aggressive behaviour in people with intellectual disabilities: A randomised controlled crossover trial
    Gast, David A. A.
    Didden, Robert
    Westera, Johanna J.
    van de Rest, Ondine
    van Hemert, Albert M.
    Giltay, Erik J.
    JOURNAL OF APPLIED RESEARCH IN INTELLECTUAL DISABILITIES, 2023, 36 (01) : 122 - 131