SepsisPhase 3LOVITNCT03680274
Lessening Organ Dysfunction With VITamin C
A Phase 3 study testing Vitamin C in people with Sepsis and Vitamin C, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
LOVIT is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in septic intensive care unit patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Vitamin C, Intensive Care Unit
- What is being tested?
- Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 872 participants
- Where
- 1 siteCanada
- Study dates
- 8 Nov 2018to 24 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the intensive care unit with proven or suspected infection as the main diagnosis;
- Currently treated with a continuous IV infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine).
Who cannot join
- > 24 hours of intensive care unit admission;
- Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency;
- Pregnancy;
- Known allergy to vitamin C;
- Known kidney stones within the past 1 year;
- Received any intravenous vitamin C during this hospitalization unless incorporated in parenteral nutrition;
Show all 10Show fewer
- Expected death or withdrawal of life-sustaining treatments within 48 hours;
- Previously enrolled in this study;
- Previously enrolled in a trial with which co-enrolment is not allowed.
- The LOVIT trial has broad eligibility criteria and includes patients with a primary diagnosis of sepsis of any cause (including sepsis caused by viral pathogens as COVID-19).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lessening Organ Dysfunction With VITamin C (LOVIT)
LOVIT is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in septic intensive care unit patients. Patients with COVID-19 are considered eligible for this study.
Read the detailed description
Background. The burden of sepsis is increasing worldwide. It is the cause of 8 million global deaths each year. Currently, treatment options are limited to antimicrobials and supportive care such as intravenous fluids, vasopressors, mechanical ventilation, and renal replacement therapy. In the absence of effective therapies specifically targeting the dysregulated immune response, prolonged use of these life-sustaining therapies can be debilitating. A growing body of evidence suggesting that vitamin C, an inexpensive and readily available intervention, is potentially lifesaving in sepsis. Intravenous vitamin C may be the first therapy to mitigate the dysregulated cascade of events that leads to sepsis. If proven effective, vitamin C could be used worldwide and drastically change outcomes in high- and low-income settings alike.
Objectives. To determine whether intravenous vitamin C, compared to placebo, reduces mortality and morbidity in sepsis (induced by bacterial and viral pathogens (as COVID-19)), and compare clinical and biochemical measures of organ dysfunction, and health-related quality of life (HRQoL) at 6 months. To ascertain the volume of distribution, clearance, and plasma concentration over a course of 96 hours of intravenous vitamin C 50 mg/kg of weight every 6 hours or matching placebo (pharmacokinetic (PK) substudy).
Methods. Patients will be randomly assigned to vitamin C (intravenous, 50 mg/kg every 6h) or placebo (0.9% NaCl or dextrose 5% in water) for 96 hours. Study personnel at the clinical sites will document the composite of death or persistent organ dysfunction at day 28. Daily assessments will occur for organ function, on days 1, 3, 7 for inflammation, infection, and endothelial injury biomarkers, at baseline for vitamin C level, and at 6 months for mortality and HRQoL. The LOVIT Trial will be conducted in adult general Canadian and international intensive care units. For the PK substudy: Blood samples will be drawn around the 8th dose at time 0 and then after administration at times 1h, 2h, 4h and 6h (the 6h level will be immediately prior to the next dose). The PK substudy will be conducted with 100 participants in 3 of the 25 participating centers.
Relevance. In the context of increasing off-label use of vitamin C for sepsis and ongoing trials of vitamin C bundled with other pharmacological interventions, the LOVIT Trial will constitute a rigorous assessment of the effect of vitamin C monotherapy on patient-important outcomes.
- Conditions
- Sepsis, Vitamin C, Intensive Care Unit, COVID-19, Pandemic, Coronavirus
- Being tested
- Vitamin C, Control
- Medical subject headings
- Sepsis, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called Ascorbic acid
Intravenous vitamin C administered in bolus doses of 50 mg/kg mixed in a 50-mL solution of either dextrose 5% in water (D5W) or normal saline (0.9% NaCl), during 30 to 60 minutes, every 6 hours for 96 hours (i.e. 200 mg/kg/day and 16 doses in total).
ControlOther
Dextrose 5% in water (D5W) or normal saline (0.9% NaCl) in a volume to match the vitamin C.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | Vitamin C: 50 mg/kg every 6 hours for 96 hours. Receives: Drug: Vitamin C |
| Control | Placebo comparator | Dextrose 5% in water (D5W) or normal saline (0.9% NaCl) in a volume to match the vitamin C. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of deceased participants or with persistent organ dysfunction
Defined as death or dependency on mechanical ventilation, renal replacement, or vasopressors
Measured: Both assessed at 28 days
Secondary outcomes (14)
Number of participants with persistent organ dysfunction-free days in intensive care unit
Persistent organ dysfunction-free days in intensive care unit
Measured: Up to day 28
Number of participants deceased at 6 months
Mortality at 6 months
Measured: 6 months
Score of health related quality of life in 6-month survivors
Assessed by the questionnaire EuroQol-5D (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: 6 months
Global tissue dysoxia
Assessed by serum lactate concentration
Measured: Days 1, 3, 7
Organ function (including renal function)
Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [μmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [μmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of each system ranges from 0 (best) to +4 (worst).
Measured: Days 1, 2, 3, 4, 7, 10, 14, 28
Rate of inflammation
Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP).
Measured: Days 1, 3, 7
Rate of infection
Assessed by procalcitonin (PCT)
Measured: Days 1, 3, 7
Rate of endothelial injury
Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Measured: Days 1, 3, 7
Occurrence of stage 3 acute kidney injury
Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Measured: Up to day 28
Acute hemolysis
- clinician judgment of hemolysis, as recorded in the chart, OR
- hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:
- reticulocyte count >2 times upper limit of normal at clinical site lab;
- haptoglobin < lower limit of normal at clinical site lab;
- indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
- Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.
Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Measured: Up to day 28
Hypoglycemia
Core lab-validated glucose level of less than 3.8 mmol/L
Measured: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose
Vitamin C volume of distribution
Assessed by chromatography-tandem mass spectrometry
Measured: 8th dose of vitamin C at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)
Vitamin C clearance
Assessed by chromatography-tandem mass spectrometry
Measured: 8th dose of vitamin C at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)
Vitamin C plasma concentration
Assessed by chromatography-tandem mass spectrometry
Measured: 8th dose of vitamin C at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start8 Nov 2018
- Primary completion15 Aug 2021
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 872 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation
- Responsible party
- Principal investigator, François Lamontagne, Université de Sherbrooke
- Investigators
- François Lamontagne, MD FRCPC MSc, Principal investigator, Université de Sherbrooke and CIUSSS de l'Estrie - CHUSNeill Adhikari, MDCM FRCPC MSc, Principal investigator, Sunnybrook Health Sciences Centre, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680274
- Sponsor's protocol ID
- MP-31-2019-2945
- Acronym
- LOVIT
- Status last verified
- Mar 2022
- First submitted
- 19 Sep 2018
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the LOVIT trial will be shared with researchers who provide a detailed and methodologically sound proposal, with specific aims. Data sharing will be for the purposes of medical research, with specific data elements provided to answer the research questions in the proposal, and under the auspices of the consent under which the data were originally gathered.
Publications
Muller MM, Pinto R, Lamontagne F, Adhikari NKJ, Del Sorbo L; Lessening Organ Dysfunction With Vitamin C (LOVIT) Investigators. Vitamin C Does Not Affect Platelet Counts in Patients With Sepsis: A Post hoc Analysis of the Lessening Organ Dysfunction With Vitamin C Randomized Trial. Crit Care Explor. 2025 Sep 5;7(9):e1310. doi: 10.1097/CCE.0000000000001310. eCollection 2025 Sep.
PubMed 40927646Rynne J, Mosavie M, Masse MH, Menard J, Battista MC, Maslove DM, Del Sorbo L, St-Arnaud C, DAragon F, Fox-Robichaud A, Charbonney E, Adhikari NKJ, Lamontagne F, Shankar-Hari M; LOVIT Investigators, the Canadian Critical Care Trials Group. Sepsis subtypes and differential treatment response to vitamin C: biological sub-study of the LOVIT trial. Intensive Care Med. 2025 Jan;51(1):82-93. doi: 10.1007/s00134-024-07733-9. Epub 2025 Jan 7.
PubMed 39774855Lamontagne F, Masse MH, Menard J, Sprague S, Pinto R, Heyland DK, Cook DJ, Battista MC, Day AG, Guyatt GH, Kanji S, Parke R, McGuinness SP, Tirupakuzhi Vijayaraghavan BK, Annane D, Cohen D, Arabi YM, Bolduc B, Marinoff N, Rochwerg B, Millen T, Meade MO, Hand L, Watpool I, Porteous R, Young PJ, D'Aragon F, Belley-Cote EP, Carbonneau E, Clarke F, Maslove DM, Hunt M, Chasse M, Lebrasseur M, Lauzier F, Mehta S, Quiroz-Martinez H, Rewa OG, Charbonney E, Seely AJE, Kutsogiannis DJ, LeBlanc R, Mekontso-Dessap A, Mele TS, Turgeon AF, Wood G, Kohli SS, Shahin J, Twardowski P, Adhikari NKJ; LOVIT Investigators and the Canadian Critical Care Trials Group. Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit. N Engl J Med. 2022 Jun 23;386(25):2387-2398. doi: 10.1056/NEJMoa2200644. Epub 2022 Jun 15.
PubMed 35704292Lachance O, Goyer F, Adhikari NKJ, Masse MH, Bilodeau JF, Lamontagne F, Leclair MA. High-dose vitamin-C induced prolonged factitious hyperglycemia in a peritoneal dialysis patient: a case report. J Med Case Rep. 2021 May 21;15(1):297. doi: 10.1186/s13256-021-02869-4.
PubMed 34020705Masse MH, Menard J, Sprague S, Battista MC, Cook DJ, Guyatt GH, Heyland DK, Kanji S, Pinto R, Day AG, Cohen D, Annane D, McGuinness S, Parke R, Carr A, Arabi Y, Vijayaraghavan BKT, D'Aragon F, Carbonneau E, Maslove D, Hunt M, Rochwerg B, Millen T, Chasse M, Lebrasseur M, Archambault P, Deblois E, Drouin C, Lellouche F, Lizotte P, Watpool I, Porteous R, Clarke F, Marinoff N, Belley-Cote E, Bolduc B, Walker S, Iazzetta J, Adhikari NKJ, Lamontagne F; Canadian Critical Care Trials Group. Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial. Trials. 2020 Jan 8;21(1):42. doi: 10.1186/s13063-019-3834-1.
PubMed 31915072
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lessening Organ Dysfunction With VITamin C (LOVIT)
- ClinicalTrials.gov ID
- NCT03680274
- Acronym / sponsor ID
- LOVIT / MP-31-2019-2945
- Conditions
- Sepsis, Vitamin C, Intensive Care Unit, COVID-19, Pandemic, Coronavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 872 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LOVIT is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in septic intensive care unit patients. Patients with COVID-19 are considered eligible for this study.
Detailed description
Background. The burden of sepsis is increasing worldwide. It is the cause of 8 million global deaths each year. Currently, treatment options are limited to antimicrobials and supportive care such as intravenous fluids, vasopressors, mechanical ventilation, and renal replacement therapy. In the absence of effective therapies specifically targeting the dysregulated immune response, prolonged use of these life-sustaining therapies can be debilitating. A growing body of evidence suggesting that vitamin C, an inexpensive and readily available intervention, is potentially lifesaving in sepsis. Intravenous vitamin C may be the first therapy to mitigate the dysregulated cascade of events that leads to sepsis. If proven effective, vitamin C could be used worldwide and drastically change outcomes in high- and low-income settings alike.
Objectives. To determine whether intravenous vitamin C, compared to placebo, reduces mortality and morbidity in sepsis (induced by bacterial and viral pathogens (as COVID-19)), and compare clinical and biochemical measures of organ dysfunction, and health-related quality of life (HRQoL) at 6 months. To ascertain the volume of distribution, clearance, and plasma concentration over a course of 96 hours of intravenous vitamin C 50 mg/kg of weight every 6 hours or matching placebo (pharmacokinetic (PK) substudy).
Methods. Patients will be randomly assigned to vitamin C (intravenous, 50 mg/kg every 6h) or placebo (0.9% NaCl or dextrose 5% in water) for 96 hours. Study personnel at the clinical sites will document the composite of death or persistent organ dysfunction at day 28. Daily assessments will occur for organ function, on days 1, 3, 7 for inflammation, infection, and endothelial injury biomarkers, at baseline for vitamin C level, and at 6 months for mortality and HRQoL. The LOVIT Trial will be conducted in adult general Canadian and international intensive care units. For the PK substudy: Blood samples will be drawn around the 8th dose at time 0 and then after administration at times 1h, 2h, 4h and 6h (the 6h level will be immediately prior to the next dose). The PK substudy will be conducted with 100 participants in 3 of the 25 participating centers.
Relevance. In the context of increasing off-label use of vitamin C for sepsis and ongoing trials of vitamin C bundled with other pharmacological interventions, the LOVIT Trial will constitute a rigorous assessment of the effect of vitamin C monotherapy on patient-important outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Drug: Vitamin CVitamin C: 50 mg/kg every 6 hours for 96 hours. |
| Control | Placebo comparator | Other: ControlDextrose 5% in water (D5W) or normal saline (0.9% NaCl) in a volume to match the vitamin C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to the intensive care unit with proven or suspected infection as the main diagnosis;
- Currently treated with a continuous IV infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine).
Key exclusion criteria (10 listed)
- > 24 hours of intensive care unit admission;
- Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency;
- Pregnancy;
- Known allergy to vitamin C;
- Known kidney stones within the past 1 year;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CAlso: Ascorbic acidIntravenous vitamin C administered in bolus doses of 50 mg/kg mixed in a 50-mL solution of either dextrose 5% in water (D5W) or normal saline (0.9% NaCl), during 30 to 60 minutes, every 6 hours for 96 hours (i.e. 200 mg/kg/day and 16 doses in total). | Drug | Vitamin C |
| ControlDextrose 5% in water (D5W) or normal saline (0.9% NaCl) in a volume to match the vitamin C. | Other | Control |
Primary outcome
Number of deceased participants or with persistent organ dysfunction
Time frame: Both assessed at 28 days
Defined as death or dependency on mechanical ventilation, renal replacement, or vasopressors
14 secondary outcomes
Number of participants with persistent organ dysfunction-free days in intensive care unit
Time frame: Up to day 28
Number of participants deceased at 6 months
Time frame: 6 months
Score of health related quality of life in 6-month survivors
Time frame: 6 months
Global tissue dysoxia
Time frame: Days 1, 3, 7
Organ function (including renal function)
Time frame: Days 1, 2, 3, 4, 7, 10, 14, 28
Rate of inflammation
Time frame: Days 1, 3, 7
Rate of infection
Time frame: Days 1, 3, 7
Rate of endothelial injury
Time frame: Days 1, 3, 7
Occurrence of stage 3 acute kidney injury
Time frame: Up to day 28
Acute hemolysis
Time frame: Up to day 28
Hypoglycemia
Time frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose
Vitamin C volume of distribution
Time frame: 8th dose of vitamin C at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)
Vitamin C clearance
Time frame: 8th dose of vitamin C at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)
Vitamin C plasma concentration
Time frame: 8th dose of vitamin C at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Derived from this study: PubMed 40927646Muller MM, Pinto R, Lamontagne F, Adhikari NKJ, Del Sorbo L; Lessening Organ Dysfunction With Vitamin C (LOVIT) Investigators. Vitamin C Does Not Affect Platelet Counts in Patients With Sepsis: A Post hoc Analysis of the Lessening Organ Dysfunction With Vitamin C Randomized Trial. Crit Care Explor. 2025 Sep 5;7(9):e1310. doi: 10.1097/CCE.0000000000001310. eCollection 2025 Sep.
- Derived from this study: PubMed 39774855Rynne J, Mosavie M, Masse MH, Menard J, Battista MC, Maslove DM, Del Sorbo L, St-Arnaud C, DAragon F, Fox-Robichaud A, Charbonney E, Adhikari NKJ, Lamontagne F, Shankar-Hari M; LOVIT Investigators, the Canadian Critical Care Trials Group. Sepsis subtypes and differential treatment response to vitamin C: biological sub-study of the LOVIT trial. Intensive Care Med. 2025 Jan;51(1):82-93. doi: 10.1007/s00134-024-07733-9. Epub 2025 Jan 7.
- Derived from this study: PubMed 35704292Lamontagne F, Masse MH, Menard J, Sprague S, Pinto R, Heyland DK, Cook DJ, Battista MC, Day AG, Guyatt GH, Kanji S, Parke R, McGuinness SP, Tirupakuzhi Vijayaraghavan BK, Annane D, Cohen D, Arabi YM, Bolduc B, Marinoff N, Rochwerg B, Millen T, Meade MO, Hand L, Watpool I, Porteous R, Young PJ, D'Aragon F, Belley-Cote EP, Carbonneau E, Clarke F, Maslove DM, Hunt M, Chasse M, Lebrasseur M, Lauzier F, Mehta S, Quiroz-Martinez H, Rewa OG, Charbonney E, Seely AJE, Kutsogiannis DJ, LeBlanc R, Mekontso-Dessap A, Mele TS, Turgeon AF, Wood G, Kohli SS, Shahin J, Twardowski P, Adhikari NKJ; LOVIT Investigators and the Canadian Critical Care Trials Group. Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit. N Engl J Med. 2022 Jun 23;386(25):2387-2398. doi: 10.1056/NEJMoa2200644. Epub 2022 Jun 15.
- Derived from this study: PubMed 34020705Lachance O, Goyer F, Adhikari NKJ, Masse MH, Bilodeau JF, Lamontagne F, Leclair MA. High-dose vitamin-C induced prolonged factitious hyperglycemia in a peritoneal dialysis patient: a case report. J Med Case Rep. 2021 May 21;15(1):297. doi: 10.1186/s13256-021-02869-4.
- Derived from this study: PubMed 31915072Masse MH, Menard J, Sprague S, Battista MC, Cook DJ, Guyatt GH, Heyland DK, Kanji S, Pinto R, Day AG, Cohen D, Annane D, McGuinness S, Parke R, Carr A, Arabi Y, Vijayaraghavan BKT, D'Aragon F, Carbonneau E, Maslove D, Hunt M, Rochwerg B, Millen T, Chasse M, Lebrasseur M, Archambault P, Deblois E, Drouin C, Lellouche F, Lizotte P, Watpool I, Porteous R, Clarke F, Marinoff N, Belley-Cote E, Bolduc B, Walker S, Iazzetta J, Adhikari NKJ, Lamontagne F; Canadian Critical Care Trials Group. Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial. Trials. 2020 Jan 8;21(1):42. doi: 10.1186/s13063-019-3834-1.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the LOVIT trial will be shared with researchers who provide a detailed and methodologically sound proposal, with specific aims. Data sharing will be for the purposes of medical research, with specific data elements provided to answer the research questions in the proposal, and under the auspices of the consent under which the data were originally gathered.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Lamontagne, MD FRCPC MSc principal investigator
Université de Sherbrooke and CIUSSS de l'Estrie - CHUS
Neill Adhikari, MDCM FRCPC MSc principal investigator
Sunnybrook Health Sciences Centre, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin C in people with Sepsis and Vitamin C, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of deceased participants or with persistent organ dysfunction (time frame: Both assessed at 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03680274, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022; AzTrials last refreshed its copy on 29 Oct 2026.