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
  • [21] Treatment with metformin glycinate reduces SARS-CoV-2 viral load: An in vitro model and randomized, double-blind, Phase IIb clinical trial
    Ventura-Lopez, Claudia
    Cervantes-Luevano, Karla
    Aguirre-Sanchez, Janet S.
    Flores-Caballero, Juan C.
    Alvarez-Delgado, Carolina
    Bernaldez-Sarabia, Johanna
    Sanchez-Campos, Noemi
    Lugo-Sanchez, Laura A.
    Rodriguez-Vazquez, Ileana C.
    Sander-Padilla, Jose G.
    Romero-Antonio, Yulia
    Arguedas-Nunez, Maria M.
    Gonzalez-Canudas, Jorge
    Licea-Navarro, Alexei F.
    BIOMEDICINE & PHARMACOTHERAPY, 2022, 152
  • [22] Interferon β-1a ring prophylaxis to reduce household transmission of SARS-CoV-2: a cluster randomised clinical trial
    Castro-Rodriguez, Jose A.
    Fish, Eleanor N.
    Montgomery, Samuel T.
    Kollmann, Tobias R.
    Iturriaga, Carolina
    Shannon, Casey
    Karpievitch, Yuliya
    Ho, Joseph
    Chen, Virginia
    Balshaw, Robert
    Ben-Othman, Rym
    Aniba, Radhouane
    Gidi-Yunge, Francisca
    Hartnell, Lucy
    Hancock, David G.
    Perez-Mateluna, Guillermo
    Urzua, Marcela
    Tebbutt, Scott J.
    Garcia-Huidobro, Diego
    Perret, Cecilia
    Borzutzky, Arturo
    Stick, Stephen M.
    ECLINICALMEDICINE, 2023, 62
  • [23] A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial
    Natalie L. McEvoy
    Jennifer L. Clarke
    Oliver J. Mc Elvaney
    Oisin F. Mc Elvaney
    Fiona Boland
    Deirdre Hyland
    Pierce Geoghegan
    Karen Donnelly
    Oisin Friel
    Ailbhe Cullen
    Ann M. Collins
    Daniel Fraughen
    Ignacio Martin-Loeches
    Martina Hennessy
    John G. Laffey
    Noel G. Mc Elvaney
    Gerard F. Curley
    Trials, 22
  • [24] A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial
    McEvoy, Natalie L.
    Clarke, Jennifer L.
    Mc Elvaney, Oliver J.
    Mc Elvaney, Oisin F.
    Boland, Fiona
    Hyland, Deirdre
    Geoghegan, Pierce
    Donnelly, Karen
    Friel, Oisin
    Cullen, Ailbhe
    Collins, Ann M.
    Fraughen, Daniel
    Martin-Loeches, Ignacio
    Hennessy, Martina
    Laffey, John G.
    Mc Elvaney, Noel G.
    Curley, Gerard F.
    TRIALS, 2021, 22 (01)
  • [25] Topical dorzolamide for macular holes: A randomised, double-blind, placebo-controlled trial
    Lee, Yong Min
    Bahrami, Bobak
    Baranage, Duleepa
    Sivagurunathan, Premala Devi
    Wong, Wilson
    Bausili, Montserrat Maria
    Agrawal, Surbhi
    Gilhotra, Jagjit Singh
    Durkin, Shane
    Sia, David
    Selva, Dinesh
    Lake, Stewart
    Casson, Robert J.
    Chan, Weng Onn
    CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY, 2024, 52 (08) : 870 - 879
  • [26] Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: Interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials
    Ozdarendeli, Aykut
    Sezer, Zafer
    Pavel, Shaikh Terkis Islam
    Inal, Ahmet
    Yetiskin, Hazel
    Kaplan, Busra
    Uygut, Muhammet Ali
    Bayram, Adnan
    Mazicioglu, Mumtaz
    Unuvar, Gamze Kalin
    Yuce, Zeynep Ture
    Aydin, Gunsu
    Aslan, Ahmet Furkan
    Kaya, Refika Kamuran
    Koc, Rabia Cakir
    Ates, Ihsan
    Kara, Ates
    VACCINE, 2023, 41 (02) : 380 - 390
  • [27] Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial
    Asano, Michiko
    Okada, Hiroshi
    Itoh, Yohji
    Hirata, Hajime
    Ishikawa, Kensuke
    Yoshida, Erika
    Matsui, Akiko
    Kelly, Elizabeth J.
    Shoemaker, Kathryn
    Olsson, Urban
    Vekemans, Johan
    INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, 2022, 114 : 165 - 174
  • [28] Safety and Immunogenicity of Betuvax-CoV-2, an RBD-Fc-Based SARS-CoV-2 Recombinant Vaccine: Preliminary Results of the First-in-Human, Randomized, Double-Blind, Placebo-Controlled Phase I/II Clinical Trial
    Kudriavtsev, Aleksandr V.
    Vakhrusheva, Anna V.
    Kryuchkov, Nickolay A.
    Frolova, Maria E.
    Blagodatskikh, Konstantin A.
    Ivanishin, Taras V.
    Djonovic, Milana
    Romanovskaya-Romanko, Ekaterina A.
    Kovalenko, Anton N.
    Lioznov, Dmitry A.
    Zubkova, Tatiana G.
    Teplykh, Svetlana V.
    Oseshnyuk, Rodion A.
    Stukova, Marina A.
    Isaev, Artur A.
    Krasilnikov, Igor V.
    VACCINES, 2023, 11 (02)
  • [29] Efficacy of a bivalent (D614+B.1.351) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, parallel, randomised, modified double-blind, placebo-controlled trial
    Dayan, Gustavo H.
    Rouphael, Nadine
    Walsh, Stephen R.
    Chen, Aiying
    Grunenberg, Nicole
    Allen, Mary
    Antony, Johannes
    Asante, Kwaku Poku
    Bhate, Amit Suresh
    Beresnev, Tatiana
    Bonaparte, Matthew, I
    Celle, Mederic
    Ceregido, Maria Angeles
    Corey, Lawrence
    Dobrianskyi, Dmytro
    Fu, Bo
    Grillet, Marie-Helene
    Keshtkar-Jahromi, Maryam
    Juraska, Michal
    Kee, Jiajin
    Kibuuka, Hannah
    Koutsoukos, Marguerite
    Masotti, Roger
    Michael, Nelson L.
    Neuzil, Kathleen M.
    Reynales, Humberto
    Robb, Merlin L.
    Martinez, Sandra M. Villagomez
    Sawe, Fredrick
    Schuerman, Lode
    Tong, Tina
    Treanor, John
    Wartel, Tanh
    Diazgranados, Carlos A.
    Chicz, Roman M.
    Gurunathan, Sanjay
    Sridhar, Saranya
    Savarino, Stephen
    LANCET RESPIRATORY MEDICINE, 2023, 11 (11) : 975 - 990
  • [30] Preventive Intake of a Multiple Micronutrient Supplement during Mild, Acute SARS-CoV-2 Infection to Reduce the Post-Acute COVID-19 Condition: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial
    Tomasa-Irriguible, Teresa Maria
    Monfa, Ramon
    Miranda-Jimenez, Cristina
    Morros, Rosa
    Robert, Neus
    Bordeje-Laguna, Luisa
    Vidal, Sandra
    Toran-Monserrat, Pere
    Barriocanal, Ana Maria
    NUTRIENTS, 2024, 16 (11)