HypertriglyceridemiaNCT06206759
Vitamin C Administration and Triglycerides Level in Critical Care Patients
An observational study of Hypertriglyceridemia, run by Meir Medical Center at 1 site in Israel.
Trial summary
Vitamin C (ascorbic acid) is a water-soluble vitamin with antioxidant properties. Previous studies showed that the administration of vitamin C was associated with decreased triglyceride (TG) levels in ambulatory patients, especially in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- administration of vitamin C
- How many people
- 2,000 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2024to 1 Feb 2027
- Phase
- Observational
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 to 99 years
- All sexes
- Adult, Older adult
Study population: patients aged 18-99 who were admitted to the general intensive care unit from January 2017 to December 2023, and who were treated with intravenous vitamin C. The control group will include patients with the same characteristics who were not treated with vitamin C.
Inclusion Criteria: patients aged 18-99 who were admitted to the general intensive care unit from January 2017 to December 2023, and who were treated with intravenous vitamin C. The control group will include patients with the same characteristics who were not treated with vitamin C.
Exclusion criteria: patients who did not meet the above conditions or for whom data were missing.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Sara Dichtwald, Dr., 972-9-7472133 ext. 1, sara.dichtwald@clalit.org.il
About this study
Official title: Vitamin C Administration and Triglycerides Level in Critical Care Patients: a Retrospective Study
Vitamin C (ascorbic acid) is a water-soluble vitamin with antioxidant properties. Previous studies showed that the administration of vitamin C was associated with decreased triglyceride (TG) levels in ambulatory patients, especially in patients with type 2 diabetes. The decrease in TG level was more significant the younger the patient's age (less than 52.8 years), the longer the administration of vitamin C lasted (over 12 weeks) and the higher the daily dose was (over 1 gram per day) (2). However, we did not find any studies that examined the relationship between administration of vitamin C and lowering of TG level in critical patients in intensive care. High TG levels are often found in these patients, secondary to sepsis, administration of propofol by continuous infusion, administration of TPN, pancreatitis, liver failure and chronic dyslipidemia, diabetes and chronic renal failure. High TG levels in these patients may cause pancreatitis secondary to elevated TG, and we take several actions to lower TG levels in the unit when they exceed 500 mg per dL in order to avoid these complications. The actions taken include starting treatment with fibrates and/or statins, giving high-dose insulin, stopping the propofol drip and changing it to another hypnotic drug (usually midazolam), and giving fat-free TPN instead of fat-containing TPN. There are of course disadvantages to these interventions, such as drug interactions, longer clearance time and higher incidence of delirium when giving midazolam compared to propofol, hypoglycemia when giving a continuous insulin drip in high doses and giving a lower amount of calories to a patient who will receive TPN without lipids.
There are many studies that examined the administration of vitamin C to patients in intensive care, especially patients with sepsis, with varied but inconclusive results. A recently published meta-analysis found a reduction in mortality among critical intensive care patients treated with intravenous vitamin C, especially in the subgroup of critically ill patients with a high risk of in-hospital mortality. The drug was found to be safe for use among patients in intensive care. In these patients in the various studies, vitamin C treatment was given intravenously in different doses, with most patients receiving a dose of 6 grams per day for 3-5 days. In light of a trend about five years ago that showed an improvement in survival among septic patients in intensive care who were treated with intravenous vitamin C as monotherapy, or in combination with steroids and/or intravenous thiamine, also in the intensive care unit at our institution (as well as in other hospitals) we started giving this treatment, at the recommended dose of 6 grams per day for 3-5 days. Over time, new studies did not find clear benefits for this treatment, so we gradually stopped giving it. However, if indeed vitamin C can contribute to a significant decrease in TG levels in patients in intensive care, there may be a point in administering it to a group of patients with high TG levels, in order to reduce complications associated with a high TG level and/or treatment to reduce it.
- Conditions
- Hypertriglyceridemia
- Being tested
- administration of vitamin C
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of vitamin CDrug
administration of vitamin C to ICU patients
| Study group | Role | What they receive |
|---|---|---|
| study group- ICU patients treated with vitamin C | ICU patients treated with vitamin C Receives: Drug: administration of vitamin C | |
| control group- ICU patients not treated with vitamin C | ICU patients not treated with vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin C administration and triglycerides level
Changes in triglycerides level (mg/dl) after 3 days of vitamin C administration (6 gr/day IV )
Measured: 1 week from Vitamin C administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 May 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206759
- Sponsor's protocol ID
- 0318-23-MMC
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided