Systemic Inflammatory Response SyndromeDEHEPTRANCT03001687
Impact of Vitamin D Supplementation on Hepcidin Levels and Transfusion Requirements in Surgical and Septic Patients
A study testing enteral supplementation with vitamin D and blood collection 3mL in people with Systemic Inflammatory Response Syndrome and Sepsis, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Acute inflammation induced by surgery and sepsis is complicated by the development of iron-restricted anemia due to the up-regulation of hepcidin. Excess hepcidin causes intracellular sequestration of iron, decreasing its availability for erythropoiesis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Inflammatory Response Syndrome, Sepsis, Surgical Injuries
- What is being tested?
- enteral supplementation with vitamin D and blood collection 3mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteRomania
- Study dates
- Jan 2017to Dec 2017
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sepsis and septic shock patients
- patients with major abdominal surgery
Who cannot join
- chronic inflammatory conditions (chronic kidney disease, hematologic, and rheumatic/autoimmune disease)
- morbid obesity (BMI over 40kg/m2)
- pregnancy and lactation
- hypercalcemia (total calcium> 10.6mg/dL, serum ionized calcium>5.4mg/dL)
- tuberculosis, sarcoidosis
- nephrolithiasis
- recent history of vitamin D supplementation or erythropoietin
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca
Cluj-Napoca, Cluj, 400012
Cristina Petrisor, MD,PhD,DESA, +40722262286, petrisor.cristina@umfcluj.ro
About this study
Official title: Impact of Vitamin D Enteral Supplementation on Hepcidin Serum Levels and Transfusion Requirements in Surgical and Critically Ill Patients
Acute inflammation induced by surgery and sepsis is complicated by the development of iron-restricted anemia due to the up-regulation of hepcidin. Excess hepcidin causes intracellular sequestration of iron, decreasing its availability for erythropoiesis. Hepcidin might be a potential target to reduce transfusion requirements in surgical and sepsis patients. Vitamin D supplementation might constitute a novel strategy to modulate the hepcidin-ferroportin-iron axis. Up to now, there are no data regarding the possibility that by using vitamin D supplementation in surgical and septic shock patients, the physicians could ameliorate anemia and, hence, reduce transfusion requirements. Aim: to conduct a randomised controlled trial to determine the impact of high-dose vitamin D enteral supplementation on serum hepcidin levels and transfusion requirements after major abdominal surgery and in septic shock patients.
Read the detailed description
Patient blood management has become an important concept for the perioperative care of the surgical patients and in septic patients, aiming to improve outcomes. Hepcidin might be a potential target to reduce transfusion requirements after major abdominal surgery and in patients with sepsis. Major surgery and sepsis induce complex immune dysregulations, characterised by a pro-inflammatory state (the postoperative acute-phase reaction). Excess hepcidin values in acute inflammatory conditions might represent an exaggerated response that leads to iron-sequestration anemia, a functional iron deficiency anemia. Vitamin D supplementation might constitute a novel strategy to modulate the hepcidin-ferroportin-iron axis in surgery and sepsis-induced acute inflammation. Thus, vitamin D might impact hepcidin values and might reduce transfusion requirements.
- Inflammation-induced regulation of the hepcidin-ferroportin-iron axis
Surgery and sepsis are associated with iron-restricted anemia. After major abdominal surgery and sepsis, a prototypical inflammatory syndrome, often complicated by the development of anemia, appears. Inflammatory cytokines (like interleukin 6) released during acute infection alter iron metabolism by inducing excess synthesis of hepcidin. Anemia after major abdominal surgery and sepsis may be the expression of impaired erythropoiesis as a result of hepcidin up-regulation. Hepcidin plays a role in the development of anemia, together with the inhibition of erythropoietin production, a decreased lifespan of erythrocytes, and a blunted erythropoietic response. Functional iron deficiency is increasingly recognised as a cause of anemia in the general surgical patient and in patients with sepsis.
Iron is a two-faced element. First, iron is essential for living as it is incorporated in the "breathing" molecule haemoglobin and in the mitochondrial respiratory chain. On the other hand, iron is detrimental due to the generation of oxidative stress and its availability for the growing of bacteria. Low serum iron level is considered detrimental as it leads to anemia and low tissue oxygen delivery. Iron deficiency and anemia are associated with poor outcomes in surgical and septic patients. Also, transfusion is associated with immune suppression and other adverse reactions. Thus, other approaches to the correction of anemia are advocated, even though not yet included in the clinical practice.
Hepcidin is the master regulator of iron metabolism and hence, a modulator of anemia in states of inflammation. Hepcidin is an acute phase protein synthetised in the liver and which acts as an hyposideremia inducing hormone. It binds to ferroportin (an iron exporter) and prevents the release of iron from the cells: prevents the absorption of dietary iron from enterocytes and prevents iron release from macrophages, where it is stored. Thus, the effect of hepcidin would be iron sequestration, lowering the serum iron concentrations. The beneficial result would be a low availability of iron for bacterial growth (thus, a direct antimicrobial effect) and less oxidative stress. The detrimental result is the limited possibility for the synthesis of new haemoglobin molecules and the occurrence of anemia. The up-regulation of hepcidin, as a pro-inflammatory biomarker, characterises both acute and chronic inflammatory conditions. The induction of hepcidin synthesis may be the cause for the iron-restricted erythropoiesis in the surgical population and in patients with sepsis. The induction of hepcidin synthesis may contribute to the development of anemia, which is detrimental for tissue oxygenation and might increase transfusion requirements and the aggravation of immune suppression after blood transfusion. In animal models of anemia due to inflammation, hepcidin knockout mice had milder anemia and faster recovery.
Excess values of the iron regulating hormone hepcidin causes intracellular sequestration of iron and might decrease the availability of iron for erythropoiesis, leading to the anemia frequently encountered in inflammatory conditions. Anemia is not only very frequent among critically ill patients, but is associated with increased transfusion rates and worse outcomes. Anemia may impair oxygen delivery to peripheral tissues and impose transfusion, which itself carries the risk of further immune suppression. Recent data has emphasised the need to restrict transfusions as much as possible, as transfusion is associated with increased morbidity and mortality. Instead, alternative methods to improve anemia and ameliorate tissue oxygen delivery might be beneficial.
II. Vitamin D down-regulates hepcidin expression
Vitamin D is a hormone promoting bone health, which also has a wide range of cellular activities including the differentiation of hematopoietic cells and down-regulation of inflammatory cytokines. Vitamin D has anti-inflammatory and immune-regulating properties and the maintenance of adequate vitamin D status may play a role in managing inflammation and immunity. Vitamin D supplementation in patients with chronic inflammatory conditions like chronic kidney disease improves the values of circulating markers of inflammation and immunity. Recently, it has been highlighted that in certain conditions, like chronic kidney disease, the administration of vitamin D reduces serum hepcidin values and transfusion requirements.
Up to now, there are no data regarding the possibility that by using vitamin D supplementation in surgical or septic shock patients, the physicians could target the hepcidin-ferroportin-iron axis to prevent the occurrence of anemia and, hence, reduce transfusion requirements. Oral vitamin D supplementation lowers hepcidin values and might increase erythropoiesis and decrease inflammation.
III. Vitamin D supplementation in the critically ill. Safety profile
The therapeutic potential of vitamin D is a topic of intense interest. A high prevalence of low vitamin D levels has been confirmed in patients who are critically ill. Vitamin D deficiency is associated with higher infection rates, 30-day mortality and in-hospital mortality in adult critically ill patients. During critical illness, vitamin D supplementation has a favorable safety profile and a possible mechanism of vitamin D supplementation in inducing bactericidal pleiotropic effects has been suggested. To improve vitamin D status, high-dose vitamin D is required in the critically ill, as they display a blunted response to supplementation. Recent evidence suggests that treatment of vitamin-D deficient critically ill patients may improve outcomes and mortality, possibly through enhancing innate immunity and the inhibition of proinflammatory cytokines. Further clinical trials to explore the effects of vitamin D supplementation on the up-regulation process of proinflammatory cytokines are needed.
- Being tested
- enteral supplementation with vitamin D, blood collection 3mL
- Keywords
- hepcidin, sepsis, surgery, vitamin D
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Sepsis, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral supplementation with vitamin DDietary supplement
Patients allocated to the "vitamin D +" group receive enteral supplementation with high-dose vitamin D (250.000UI)
blood collection 3mLOther
all patients will have hepcidin levels measured in the first 24 hours after admission and one week after
| Study group | Role | What they receive |
|---|---|---|
| vitamin D + | Experimental | Patients in the "vitamin D" group will receive enteral supplementation with vitamin D, blood collection 3mL is performed in the first 24 hours after admission and one week later for serum hepcidin measurement Receives: Dietary Supplement: enteral supplementation with vitamin D; Other: blood collection 3mL |
| vitamin D - | Placebo comparator | Patients in "vitamin D -" group do not receive enteral supplementation with vitamin D and represent the control group, blood collection 3mL is performed in the first 24 hours after admission and one week later for serum hepcidin measurement Receives: Other: blood collection 3mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepcidin concentration (ng/mL)
Hepcidin serum concentrations measured one week after the intervention
Measured: one week after intervention
Secondary outcomes (1)
Number of Packed red cells
The number of transfused packed red cells in the first two weeks after the intervention
Measured: two weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory Response SyndromeStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Petrisor, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Cristina Petrisor, MD, PhD, Principal investigator, University of Medicine and Pharmacy Iuliu Hatieganu Cluj-Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001687
- Sponsor's protocol ID
- 434/24.11.2016
- Acronym
- DEHEPTRA
- Status last verified
- Dec 2016
- First submitted
- 13 Dec 2016
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only on request
Publications
Lasocki S, Longrois D, Montravers P, Beaumont C. Hepcidin and anemia of the critically ill patient: bench to bedside. Anesthesiology. 2011 Mar;114(3):688-94. doi: 10.1097/ALN.0b013e3182065c57. No abstract available.
PubMed 21258235Clevenger B, Richards T. Pre-operative anaemia. Anaesthesia. 2015 Jan;70 Suppl 1:20-8, e6-8. doi: 10.1111/anae.12918.
PubMed 25440391Heming N, Montravers P, Lasocki S. Iron deficiency in critically ill patients: highlighting the role of hepcidin. Crit Care. 2011;15(2):210. doi: 10.1186/cc9992. Epub 2011 Mar 22. No abstract available.
PubMed 21457511Lasocki S, Gaillard T, Rineau E. Iron is essential for living! Crit Care. 2014 Dec 8;18(6):678. doi: 10.1186/s13054-014-0678-7.
PubMed 25673336Heming N, Letteron P, Driss F, Millot S, El Benna J, Tourret J, Denamur E, Montravers P, Beaumont C, Lasocki S. Efficacy and toxicity of intravenous iron in a mouse model of critical care anemia*. Crit Care Med. 2012 Jul;40(7):2141-8. doi: 10.1097/CCM.0b013e31824e6713.
PubMed 22564959Zeng C, Chen Q, Zhang K, Chen Q, Song S, Fang X. Hepatic hepcidin protects against polymicrobial sepsis in mice by regulating host iron status. Anesthesiology. 2015 Feb;122(2):374-86. doi: 10.1097/ALN.0000000000000466.
PubMed 25264597Kali A, Charles MV, Seetharam RS. Hepcidin - A novel biomarker with changing trends. Pharmacogn Rev. 2015 Jan-Jun;9(17):35-40. doi: 10.4103/0973-7847.156333.
PubMed 26009691Ruchala P, Nemeth E. The pathophysiology and pharmacology of hepcidin. Trends Pharmacol Sci. 2014 Mar;35(3):155-61. doi: 10.1016/j.tips.2014.01.004. Epub 2014 Feb 17.
PubMed 24552640Kim A, Fung E, Parikh SG, Valore EV, Gabayan V, Nemeth E, Ganz T. A mouse model of anemia of inflammation: complex pathogenesis with partial dependence on hepcidin. Blood. 2014 Feb 20;123(8):1129-36. doi: 10.1182/blood-2013-08-521419. Epub 2013 Dec 19.
PubMed 24357728Meybohm P, Shander A, Zacharowski K. Should we restrict erythrocyte transfusion in early goal directed protocols? BMC Anesthesiol. 2015 May 9;15:75. doi: 10.1186/s12871-015-0054-4.
PubMed 25956725Shah A, Stanworth SJ, McKechnie S. Evidence and triggers for the transfusion of blood and blood products. Anaesthesia. 2015 Jan;70 Suppl 1:10-9, e3-5. doi: 10.1111/anae.12893.
PubMed 25440390Sadaka F, Trottier S, Tannehill D, Donnelly PL, Griffin MT, Bunaye Z, O'Brien J, Korobey M, Lakshmanan R. Transfusion of red blood cells is associated with improved central venous oxygen saturation but not mortality in septic shock patients. J Clin Med Res. 2014 Dec;6(6):422-8. doi: 10.14740/jocmr1843w. Epub 2014 Sep 9.
PubMed 25247015Sun CC, Vaja V, Chen S, Theurl I, Stepanek A, Brown DE, Cappellini MD, Weiss G, Hong CC, Lin HY, Babitt JL. A hepcidin lowering agent mobilizes iron for incorporation into red blood cells in an adenine-induced kidney disease model of anemia in rats. Nephrol Dial Transplant. 2013 Jul;28(7):1733-43. doi: 10.1093/ndt/gfs584. Epub 2013 Jan 22.
PubMed 23345622Alvarez JA, Zughaier SM, Law J, Hao L, Wasse H, Ziegler TR, Tangpricha V. Effects of high-dose cholecalciferol on serum markers of inflammation and immunity in patients with early chronic kidney disease. Eur J Clin Nutr. 2013 Mar;67(3):264-9. doi: 10.1038/ejcn.2012.217. Epub 2013 Jan 30.
PubMed 23361158Smith EM, Tangpricha V. Vitamin D and anemia: insights into an emerging association. Curr Opin Endocrinol Diabetes Obes. 2015 Dec;22(6):432-8. doi: 10.1097/MED.0000000000000199.
PubMed 26414080
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Enteral Supplementation on Hepcidin Serum Levels and Transfusion Requirements in Surgical and Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03001687
- Acronym / sponsor ID
- DEHEPTRA / 434/24.11.2016
- Keywords
- hepcidin, sepsis, surgery, vitamin D
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Dec 2016 (estimated)
- 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.
Acute inflammation induced by surgery and sepsis is complicated by the development of iron-restricted anemia due to the up-regulation of hepcidin. Excess hepcidin causes intracellular sequestration of iron, decreasing its availability for erythropoiesis. Hepcidin might be a potential target to reduce transfusion requirements in surgical and sepsis patients. Vitamin D supplementation might constitute a novel strategy to modulate the hepcidin-ferroportin-iron axis. Up to now, there are no data regarding the possibility that by using vitamin D supplementation in surgical and septic shock patients, the physicians could ameliorate anemia and, hence, reduce transfusion requirements. Aim: to conduct a randomised controlled trial to determine the impact of high-dose vitamin D enteral supplementation on serum hepcidin levels and transfusion requirements after major abdominal surgery and in septic shock patients.
Detailed description
Patient blood management has become an important concept for the perioperative care of the surgical patients and in septic patients, aiming to improve outcomes. Hepcidin might be a potential target to reduce transfusion requirements after major abdominal surgery and in patients with sepsis. Major surgery and sepsis induce complex immune dysregulations, characterised by a pro-inflammatory state (the postoperative acute-phase reaction). Excess hepcidin values in acute inflammatory conditions might represent an exaggerated response that leads to iron-sequestration anemia, a functional iron deficiency anemia. Vitamin D supplementation might constitute a novel strategy to modulate the hepcidin-ferroportin-iron axis in surgery and sepsis-induced acute inflammation. Thus, vitamin D might impact hepcidin values and might reduce transfusion requirements.
- Inflammation-induced regulation of the hepcidin-ferroportin-iron axis
Surgery and sepsis are associated with iron-restricted anemia. After major abdominal surgery and sepsis, a prototypical inflammatory syndrome, often complicated by the development of anemia, appears. Inflammatory cytokines (like interleukin 6) released during acute infection alter iron metabolism by inducing excess synthesis of hepcidin. Anemia after major abdominal surgery and sepsis may be the expression of impaired erythropoiesis as a result of hepcidin up-regulation. Hepcidin plays a role in the development of anemia, together with the inhibition of erythropoietin production, a decreased lifespan of erythrocytes, and a blunted erythropoietic response. Functional iron deficiency is increasingly recognised as a cause of anemia in the general surgical patient and in patients with sepsis.
Iron is a two-faced element. First, iron is essential for living as it is incorporated in the "breathing" molecule haemoglobin and in the mitochondrial respiratory chain. On the other hand, iron is detrimental due to the generation of oxidative stress and its availability for the growing of bacteria. Low serum iron level is considered detrimental as it leads to anemia and low tissue oxygen delivery. Iron deficiency and anemia are associated with poor outcomes in surgical and septic patients. Also, transfusion is associated with immune suppression and other adverse reactions. Thus, other approaches to the correction of anemia are advocated, even though not yet included in the clinical practice.
Hepcidin is the master regulator of iron metabolism and hence, a modulator of anemia in states of inflammation. Hepcidin is an acute phase protein synthetised in the liver and which acts as an hyposideremia inducing hormone. It binds to ferroportin (an iron exporter) and prevents the release of iron from the cells: prevents the absorption of dietary iron from enterocytes and prevents iron release from macrophages, where it is stored. Thus, the effect of hepcidin would be iron sequestration, lowering the serum iron concentrations. The beneficial result would be a low availability of iron for bacterial growth (thus, a direct antimicrobial effect) and less oxidative stress. The detrimental result is the limited possibility for the synthesis of new haemoglobin molecules and the occurrence of anemia. The up-regulation of hepcidin, as a pro-inflammatory biomarker, characterises both acute and chronic inflammatory conditions. The induction of hepcidin synthesis may be the cause for the iron-restricted erythropoiesis in the surgical population and in patients with sepsis. The induction of hepcidin synthesis may contribute to the development of anemia, which is detrimental for tissue oxygenation and might increase transfusion requirements and the aggravation of immune suppression after blood transfusion. In animal models of anemia due to inflammation, hepcidin knockout mice had milder anemia and faster recovery.
Excess values of the iron regulating hormone hepcidin causes intracellular sequestration of iron and might decrease the availability of iron for erythropoiesis, leading to the anemia frequently encountered in inflammatory conditions. Anemia is not only very frequent among critically ill patients, but is associated with increased transfusion rates and worse outcomes. Anemia may impair oxygen delivery to peripheral tissues and impose transfusion, which itself carries the risk of further immune suppression. Recent data has emphasised the need to restrict transfusions as much as possible, as transfusion is associated with increased morbidity and mortality. Instead, alternative methods to improve anemia and ameliorate tissue oxygen delivery might be beneficial.
II. Vitamin D down-regulates hepcidin expression
Vitamin D is a hormone promoting bone health, which also has a wide range of cellular activities including the differentiation of hematopoietic cells and down-regulation of inflammatory cytokines. Vitamin D has anti-inflammatory and immune-regulating properties and the maintenance of adequate vitamin D status may play a role in managing inflammation and immunity. Vitamin D supplementation in patients with chronic inflammatory conditions like chronic kidney disease improves the values of circulating markers of inflammation and immunity. Recently, it has been highlighted that in certain conditions, like chronic kidney disease, the administration of vitamin D reduces serum hepcidin values and transfusion requirements.
Up to now, there are no data regarding the possibility that by using vitamin D supplementation in surgical or septic shock patients, the physicians could target the hepcidin-ferroportin-iron axis to prevent the occurrence of anemia and, hence, reduce transfusion requirements. Oral vitamin D supplementation lowers hepcidin values and might increase erythropoiesis and decrease inflammation.
III. Vitamin D supplementation in the critically ill. Safety profile
The therapeutic potential of vitamin D is a topic of intense interest. A high prevalence of low vitamin D levels has been confirmed in patients who are critically ill. Vitamin D deficiency is associated with higher infection rates, 30-day mortality and in-hospital mortality in adult critically ill patients. During critical illness, vitamin D supplementation has a favorable safety profile and a possible mechanism of vitamin D supplementation in inducing bactericidal pleiotropic effects has been suggested. To improve vitamin D status, high-dose vitamin D is required in the critically ill, as they display a blunted response to supplementation. Recent evidence suggests that treatment of vitamin-D deficient critically ill patients may improve outcomes and mortality, possibly through enhancing innate immunity and the inhibition of proinflammatory cytokines. Further clinical trials to explore the effects of vitamin D supplementation on the up-regulation process of proinflammatory cytokines are needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D + | Experimental | Dietary Supplement: enteral supplementation with vitamin D, Other: blood collection 3mLPatients in the "vitamin D" group will receive enteral supplementation with vitamin D, blood collection 3mL is performed in the first 24 hours after admission and one week later for serum hepcidin measurement |
| vitamin D - | Placebo comparator | Other: blood collection 3mLPatients in "vitamin D -" group do not receive enteral supplementation with vitamin D and represent the control group, blood collection 3mL is performed in the first 24 hours after admission and one week later for serum hepcidin measurement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sepsis and septic shock patients
- patients with major abdominal surgery
Key exclusion criteria (7 listed)
- chronic inflammatory conditions (chronic kidney disease, hematologic, and rheumatic/autoimmune disease)
- morbid obesity (BMI over 40kg/m2)
- pregnancy and lactation
- hypercalcemia (total calcium> 10.6mg/dL, serum ionized calcium>5.4mg/dL)
- tuberculosis, sarcoidosis
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 |
|---|---|---|
| enteral supplementation with vitamin DPatients allocated to the "vitamin D +" group receive enteral supplementation with high-dose vitamin D (250.000UI) | Dietary supplement | vitamin D + |
| blood collection 3mLall patients will have hepcidin levels measured in the first 24 hours after admission and one week after | Other | vitamin D +, vitamin D - |
Primary outcome
Hepcidin concentration (ng/mL)
Time frame: one week after intervention
Hepcidin serum concentrations measured one week after the intervention
1 secondary outcome
Number of Packed red cells
Time frame: two weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Background: PubMed 21258235Lasocki S, Longrois D, Montravers P, Beaumont C. Hepcidin and anemia of the critically ill patient: bench to bedside. Anesthesiology. 2011 Mar;114(3):688-94. doi: 10.1097/ALN.0b013e3182065c57. No abstract available.
- Background: PubMed 25440391Clevenger B, Richards T. Pre-operative anaemia. Anaesthesia. 2015 Jan;70 Suppl 1:20-8, e6-8. doi: 10.1111/anae.12918.
- Background: PubMed 21457511Heming N, Montravers P, Lasocki S. Iron deficiency in critically ill patients: highlighting the role of hepcidin. Crit Care. 2011;15(2):210. doi: 10.1186/cc9992. Epub 2011 Mar 22. No abstract available.
- Background: PubMed 25673336Lasocki S, Gaillard T, Rineau E. Iron is essential for living! Crit Care. 2014 Dec 8;18(6):678. doi: 10.1186/s13054-014-0678-7.
- Background: PubMed 22564959Heming N, Letteron P, Driss F, Millot S, El Benna J, Tourret J, Denamur E, Montravers P, Beaumont C, Lasocki S. Efficacy and toxicity of intravenous iron in a mouse model of critical care anemia*. Crit Care Med. 2012 Jul;40(7):2141-8. doi: 10.1097/CCM.0b013e31824e6713.
- Background: PubMed 25264597Zeng C, Chen Q, Zhang K, Chen Q, Song S, Fang X. Hepatic hepcidin protects against polymicrobial sepsis in mice by regulating host iron status. Anesthesiology. 2015 Feb;122(2):374-86. doi: 10.1097/ALN.0000000000000466.
- Background: PubMed 26009691Kali A, Charles MV, Seetharam RS. Hepcidin - A novel biomarker with changing trends. Pharmacogn Rev. 2015 Jan-Jun;9(17):35-40. doi: 10.4103/0973-7847.156333.
- Background: PubMed 24552640Ruchala P, Nemeth E. The pathophysiology and pharmacology of hepcidin. Trends Pharmacol Sci. 2014 Mar;35(3):155-61. doi: 10.1016/j.tips.2014.01.004. Epub 2014 Feb 17.
- Background: PubMed 24357728Kim A, Fung E, Parikh SG, Valore EV, Gabayan V, Nemeth E, Ganz T. A mouse model of anemia of inflammation: complex pathogenesis with partial dependence on hepcidin. Blood. 2014 Feb 20;123(8):1129-36. doi: 10.1182/blood-2013-08-521419. Epub 2013 Dec 19.
- Background: PubMed 25956725Meybohm P, Shander A, Zacharowski K. Should we restrict erythrocyte transfusion in early goal directed protocols? BMC Anesthesiol. 2015 May 9;15:75. doi: 10.1186/s12871-015-0054-4.
- Background: PubMed 25440390Shah A, Stanworth SJ, McKechnie S. Evidence and triggers for the transfusion of blood and blood products. Anaesthesia. 2015 Jan;70 Suppl 1:10-9, e3-5. doi: 10.1111/anae.12893.
- Background: PubMed 25247015Sadaka F, Trottier S, Tannehill D, Donnelly PL, Griffin MT, Bunaye Z, O'Brien J, Korobey M, Lakshmanan R. Transfusion of red blood cells is associated with improved central venous oxygen saturation but not mortality in septic shock patients. J Clin Med Res. 2014 Dec;6(6):422-8. doi: 10.14740/jocmr1843w. Epub 2014 Sep 9.
- Individual participant dataSharing planned: No. Only on request
Related trials for Systemic Inflammatory Response Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Cristina Petrisor, MD, PhD principal investigator
University of Medicine and Pharmacy Iuliu Hatieganu Cluj-Napoca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral supplementation with vitamin D and blood collection 3mL in people with Systemic Inflammatory Response Syndrome and Sepsis, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 7 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: status not confirmed, as of the sponsor's last update on 6 Feb 2017. 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 Romania. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luminita Goga (+40-264-597-256, contact@umfcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepcidin concentration (ng/mL) (time frame: one week after intervention). 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 NCT03001687, which also lists 28 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 6 Feb 2017.