Critically IllPhase 4NCT04536831
The Association of Vitamin D Supplementation With the Outcome in Critically Ill Children
A Phase 4 study testing Vitamin D and Normal saline in people with Critically Ill, run by Dr Mustahsin Khalil at 1 site in Pakistan.
Trial summary
Vitamin D deficiency is highly prevalent in critically ill adult and pediatric population that causes multiple adverse health outcomes including higher illness severity score, increased morbidity and mortality, multiple organ dysfunction, longer duration of Mechanical ventilation, longer duration of Oxygen therapy and… Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Critically Ill
- What is being tested?
- Vitamin D and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Aug 2019to 25 Feb 2020
- Phase
- Phase 4
- 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 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of age 6 months to 10 years, either gender admitted in ICU for critical illness (on medical record) with PIM-2 score suggesting probability of mortality more than 50%.
Who cannot join
- Children with known adrenal, pituitary, hypothalamic or thyroid disease.
- Those who have complex congenital defects.
- Moribund at time of admission.
- Those who were expected to be care withdrawn.
- Patients who had received large dose regimen (200,000 IU or more) of vitamin D during the previous three months before admission.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
King Edward Medical University Lahore
Lahore, Punjab Province, 39500
About this study
Vitamin D deficiency is highly prevalent in critically ill adult and pediatric population that causes multiple adverse health outcomes including higher illness severity score, increased morbidity and mortality, multiple organ dysfunction, longer duration of Mechanical ventilation, longer duration of Oxygen therapy and increased length of stay (LOS) in PICU and hospital. Vitamin D deficiency is a modifiable risk factor that can be corrected with high dose of vitamin D supplementation to improve the clinical outcome.
This study is designed to determine whether random vitamin D supplementation within dose limits improves clinical outcomes in critically ill children.
Read the detailed description
Vitamin D is known for its role in bone metabolism and calcium haemostasis but it is also required for the optimal functioning of cardiovascular and innate immune systems.
As a pleiotropic hormone it has been increasingly implicated in proper functioning of multiple organs; its deficiency is associated with cardiovascular diseases, asthma, cancer, multiple sclerosis, diabetes and acute lower respiratory tract infections. Over one billion people are vitamin D deficient worldwide and in Pakistani population vitamin D deficiency is reported as high as 76% despite abundant sunshine.
Beside of ambulatory individuals, the patients presenting in intensive care units are also found Vitamin D deficient. In adult intensive care settings studies have shown vitamin D deficiency (VDD) present in 60% of critically ill adult patients.VDD is also very common in pediatric intensive care units (PICU) worldwide, ranging from 30 to 80%.
Although there is high prevalence of VDD in pediatric and adult population, but there is no uniform definition of VDD exists. Levels of active metabolite 1,25(OH)2D of Vitamin D at tissue level cannot be measured, however, patient's blood level of 25-hydroxy vitamin D is used to know vitamin D stores in the body. Patient with serum vitamin D level<20ng/ml is considered to be vitamin D deficient.
VDD is associated with clinically poor outcomes like increased duration of mechanical ventilation, increased length of hospital stay, Sepsis, Acute respiratory failure and mortality in critically ill patients.
The existing evidences suggest that Vitamin D3 supplementation enhances recovery from influenza, recurrent pneumonias and tuberculosis. Recently, an observational study of adult patients suggested that patients with VDD showed decrease in the odds of all cause-mortality when their Vitamin D status was improved before hospitalization.
A randomized study demonstrated that one time bolus dose of oral vitamin D supplementation caused decrease in mortality in a group of patients with severe VDD.
A significant literature is available that suggests vitamin D deficiency as a modifiable risk factor in PICU settings. The recognized importance of vitamin D to the health of multiple organ systems suggest that rapid normalization could represent a simple, inexpensive, and safe means of improving outcomes and reducing health care spending.
This study is designed to supplement large dose of vitamin D that may lead to fast correction of low vitamin D level in critically ill children and possibility of better clinical outcome. If such an association is established by this study, routine detection and use of Vitamin D might be recommended for critically ill children admitted to PICU.
- Conditions
- Critically Ill
- Being tested
- Vitamin D, Normal saline
- Keywords
- vitamin D, Supplimentation, Critically ill children
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called vitamin D3
Vitamin D will be given to group A selected by Lottery method
Normal salineDrug
Vitamin D will be given to group B slected by Lottery method
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | Consisted of 48 patients selected on admission via lottery method those will be given Vitamin D mega dose Receives: Drug: Vitamin D |
| Normal Saline group | Placebo comparator | Consisted of 48 patients selected on admission via lottery method those will be given Normal saline Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Patient is declared dead by duty doctor
Measured: upto one month
Discharge
Patient became vitally stable and shifted out of PICU
Measured: upto one month
Secondary outcomes (4)
Duration of O2 therapy
Total time that patient required O2
Measured: upto one month
Duration of Mechanical ventilation
Total time of Mechanical ventilation required by the patient
Measured: upto one month
Duration of PICU stay
Total Duration of stay in PICU
Measured: upto one month
Duration of Hospital stay.
Total duration of Hospital stay in wards except PICU stay
Measured: upto one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start29 Aug 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Mustahsin Khalil
- Sponsor type
- University, hospital or other
- Collaborators
- King Edward Medical University
- Responsible party
- Sponsor-investigator, Dr Mustahsin Khalil, King Edward Medical University
- Investigators
- Mustahsin khalil Ahmad, MBBS, Principal investigator, KEMU Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536831
- Sponsor's protocol ID
- MKA1
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McNally JD, Menon K, Chakraborty P, Fisher L, Williams KA, Al-Dirbashi OY, Doherty DR; Canadian Critical Care Trials Group. The association of vitamin D status with pediatric critical illness. Pediatrics. 2012 Sep;130(3):429-36. doi: 10.1542/peds.2011-3059. Epub 2012 Aug 6.
PubMed 22869837McNally JD, Iliriani K, Pojsupap S, Sampson M, O'Hearn K, McIntyre L, Fergusson D, Menon K. Rapid normalization of vitamin D levels: a meta-analysis. Pediatrics. 2015 Jan;135(1):e152-66. doi: 10.1542/peds.2014-1703. Epub 2014 Dec 15.
PubMed 25511115Hossain N, Khanani R, Hussain-Kanani F, Shah T, Arif S, Pal L. High prevalence of vitamin D deficiency in Pakistani mothers and their newborns. Int J Gynaecol Obstet. 2011 Mar;112(3):229-33. doi: 10.1016/j.ijgo.2010.09.017. Epub 2011 Jan 17.
PubMed 21247568Mahmood K, Akhtar ST, Talib A, Haider I. Vitamin-D status in a population of healthy adults in Pakistan. Pak J Med Sci. 2009;25(4):545-50.
Riaz H, Finlayson AE, Bashir S, Hussain S, Mahmood S, Malik F, Godman B. Prevalence of Vitamin D deficiency in Pakistan and implications for the future. Expert Rev Clin Pharmacol. 2016;9(2):329-38. doi: 10.1586/17512433.2016.1122519. Epub 2016 Jan 13.
PubMed 26582317Amrein K, Schnedl C, Holl A, Riedl R, Christopher KB, Pachler C, Urbanic Purkart T, Waltensdorfer A, Munch A, Warnkross H, Stojakovic T, Bisping E, Toller W, Smolle KH, Berghold A, Pieber TR, Dobnig H. Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA. 2014 Oct 15;312(15):1520-30. doi: 10.1001/jama.2014.13204.
PubMed 25268295McNally D, Amrein K, O'Hearn K, Fergusson D, Geier P, Henderson M, Khamessan A, Lawson ML, McIntyre L, Redpath S, Weiler HA, Menon K; Canadian Critical Care Trials Group. Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study). Pilot Feasibility Stud. 2017 Dec 8;3:70. doi: 10.1186/s40814-017-0214-z. eCollection 2017.
PubMed 29234503Angurana SK. Serum Vitamin D Status and Outcome among Critically Ill Children Admitted to the Pediatric Intensive Care Unit in South India: Correspondence. Indian J Pediatr. 2016 Aug;83(8):910-1. doi: 10.1007/s12098-015-1992-z. Epub 2016 Jan 14. No abstract available.
PubMed 26762331Madden K, Feldman HA, Smith EM, Gordon CM, Keisling SM, Sullivan RM, Hollis BW, Agan AA, Randolph AG. Vitamin D deficiency in critically ill children. Pediatrics. 2012 Sep;130(3):421-8. doi: 10.1542/peds.2011-3328. Epub 2012 Aug 6.
PubMed 22869836Han JE, Jones JL, Tangpricha V, Brown MA, Brown LAS, Hao L, Hebbar G, Lee MJ, Liu S, Ziegler TR, Martin GS. High Dose Vitamin D Administration in Ventilated Intensive Care Unit Patients: A Pilot Double Blind Randomized Controlled Trial. J Clin Transl Endocrinol. 2016 Jun;4:59-65. doi: 10.1016/j.jcte.2016.04.004. Epub 2016 May 5.
PubMed 27419080Amrein K, Litonjua AA, Moromizato T, Quraishi SA, Gibbons FK, Pieber TR, Camargo CA Jr, Giovannucci E, Christopher KB. Increases in pre-hospitalization serum 25(OH)D concentrations are associated with improved 30-day mortality after hospital admission: A cohort study. Clin Nutr. 2016 Apr;35(2):514-521. doi: 10.1016/j.clnu.2015.03.020. Epub 2015 Apr 14.
PubMed 25935851Amrein K, Sourij H, Wagner G, Holl A, Pieber TR, Smolle KH, Stojakovic T, Schnedl C, Dobnig H. Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study. Crit Care. 2011;15(2):R104. doi: 10.1186/cc10120. Epub 2011 Mar 28.
PubMed 21443793Williams S, Heuberger R. Outcomes of Vitamin D Supplementation in Adults Who are Deficient and Critically Ill: A Review of the Literature. Am J Ther. 2016 Nov/Dec;23(6):e1890-e1902. doi: 10.1097/MJT.0000000000000281.
PubMed 26164022Gandhi J, Sangareddi S, Varadarajan P, Suresh S. Pediatric index of mortality 2 score as an outcome predictor in pediatric Intensive Care Unit in India. Indian J Crit Care Med. 2013 Sep;17(5):288-91. doi: 10.4103/0972-5229.120320.
PubMed 24339640Greenbaum LA. Rickets and Hypervitaminosis. In: Kliegman RM, Stanton BF, Geme III JW, Schor NF. (eds). Nelson Textbook Of Pediatrics. 20th ed. Philadelphia: Elsevier; 2016. p.331-38.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Vitamin D Supplementation With the Outcome in Critically Ill Children
- ClinicalTrials.gov ID
- NCT04536831
- Acronym / sponsor ID
- MKA1
- Conditions
- Critically Ill
- Keywords
- vitamin D, Supplimentation, Critically ill children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Dr Mustahsin KhalilUniversity, hospital or other
- Collaborators
- King Edward Medical University
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 3 Sep 2020 (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.
Vitamin D deficiency is highly prevalent in critically ill adult and pediatric population that causes multiple adverse health outcomes including higher illness severity score, increased morbidity and mortality, multiple organ dysfunction, longer duration of Mechanical ventilation, longer duration of Oxygen therapy and increased length of stay (LOS) in PICU and hospital. Vitamin D deficiency is a modifiable risk factor that can be corrected with high dose of vitamin D supplementation to improve the clinical outcome.
This study is designed to determine whether random vitamin D supplementation within dose limits improves clinical outcomes in critically ill children.
Detailed description
Vitamin D is known for its role in bone metabolism and calcium haemostasis but it is also required for the optimal functioning of cardiovascular and innate immune systems.
As a pleiotropic hormone it has been increasingly implicated in proper functioning of multiple organs; its deficiency is associated with cardiovascular diseases, asthma, cancer, multiple sclerosis, diabetes and acute lower respiratory tract infections. Over one billion people are vitamin D deficient worldwide and in Pakistani population vitamin D deficiency is reported as high as 76% despite abundant sunshine.
Beside of ambulatory individuals, the patients presenting in intensive care units are also found Vitamin D deficient. In adult intensive care settings studies have shown vitamin D deficiency (VDD) present in 60% of critically ill adult patients.VDD is also very common in pediatric intensive care units (PICU) worldwide, ranging from 30 to 80%.
Although there is high prevalence of VDD in pediatric and adult population, but there is no uniform definition of VDD exists. Levels of active metabolite 1,25(OH)2D of Vitamin D at tissue level cannot be measured, however, patient's blood level of 25-hydroxy vitamin D is used to know vitamin D stores in the body. Patient with serum vitamin D level<20ng/ml is considered to be vitamin D deficient.
VDD is associated with clinically poor outcomes like increased duration of mechanical ventilation, increased length of hospital stay, Sepsis, Acute respiratory failure and mortality in critically ill patients.
The existing evidences suggest that Vitamin D3 supplementation enhances recovery from influenza, recurrent pneumonias and tuberculosis. Recently, an observational study of adult patients suggested that patients with VDD showed decrease in the odds of all cause-mortality when their Vitamin D status was improved before hospitalization.
A randomized study demonstrated that one time bolus dose of oral vitamin D supplementation caused decrease in mortality in a group of patients with severe VDD.
A significant literature is available that suggests vitamin D deficiency as a modifiable risk factor in PICU settings. The recognized importance of vitamin D to the health of multiple organ systems suggest that rapid normalization could represent a simple, inexpensive, and safe means of improving outcomes and reducing health care spending.
This study is designed to supplement large dose of vitamin D that may lead to fast correction of low vitamin D level in critically ill children and possibility of better clinical outcome. If such an association is established by this study, routine detection and use of Vitamin D might be recommended for critically ill children admitted to PICU.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Drug: Vitamin DConsisted of 48 patients selected on admission via lottery method those will be given Vitamin D mega dose |
| Normal Saline group | Placebo comparator | Drug: Normal salineConsisted of 48 patients selected on admission via lottery method those will be given Normal saline |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children of age 6 months to 10 years, either gender admitted in ICU for critical illness (on medical record) with PIM-2 score suggesting probability of mortality more than 50%.
Key exclusion criteria (5 listed)
- Children with known adrenal, pituitary, hypothalamic or thyroid disease.
- Those who have complex congenital defects.
- Moribund at time of admission.
- Those who were expected to be care withdrawn.
- Patients who had received large dose regimen (200,000 IU or more) of vitamin D during the previous three months before admission.
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 DAlso: vitamin D3Vitamin D will be given to group A selected by Lottery method | Drug | Vitamin D group |
| Normal salineVitamin D will be given to group B slected by Lottery method | Drug | Normal Saline group |
Primary outcome
Death
Time frame: upto one month
Patient is declared dead by duty doctor
Discharge
Time frame: upto one month
Patient became vitally stable and shifted out of PICU
4 secondary outcomes
Duration of O2 therapy
Time frame: upto one month
Duration of Mechanical ventilation
Time frame: upto one month
Duration of PICU stay
Time frame: upto one month
Duration of Hospital stay.
Time frame: upto one month
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 3 Sep 2020.
- Background: PubMed 22869837McNally JD, Menon K, Chakraborty P, Fisher L, Williams KA, Al-Dirbashi OY, Doherty DR; Canadian Critical Care Trials Group. The association of vitamin D status with pediatric critical illness. Pediatrics. 2012 Sep;130(3):429-36. doi: 10.1542/peds.2011-3059. Epub 2012 Aug 6.
- Background: PubMed 25511115McNally JD, Iliriani K, Pojsupap S, Sampson M, O'Hearn K, McIntyre L, Fergusson D, Menon K. Rapid normalization of vitamin D levels: a meta-analysis. Pediatrics. 2015 Jan;135(1):e152-66. doi: 10.1542/peds.2014-1703. Epub 2014 Dec 15.
- Background: PubMed 21247568Hossain N, Khanani R, Hussain-Kanani F, Shah T, Arif S, Pal L. High prevalence of vitamin D deficiency in Pakistani mothers and their newborns. Int J Gynaecol Obstet. 2011 Mar;112(3):229-33. doi: 10.1016/j.ijgo.2010.09.017. Epub 2011 Jan 17.
- BackgroundMahmood K, Akhtar ST, Talib A, Haider I. Vitamin-D status in a population of healthy adults in Pakistan. Pak J Med Sci. 2009;25(4):545-50.
- Background: PubMed 26582317Riaz H, Finlayson AE, Bashir S, Hussain S, Mahmood S, Malik F, Godman B. Prevalence of Vitamin D deficiency in Pakistan and implications for the future. Expert Rev Clin Pharmacol. 2016;9(2):329-38. doi: 10.1586/17512433.2016.1122519. Epub 2016 Jan 13.
- Background: PubMed 25268295Amrein K, Schnedl C, Holl A, Riedl R, Christopher KB, Pachler C, Urbanic Purkart T, Waltensdorfer A, Munch A, Warnkross H, Stojakovic T, Bisping E, Toller W, Smolle KH, Berghold A, Pieber TR, Dobnig H. Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA. 2014 Oct 15;312(15):1520-30. doi: 10.1001/jama.2014.13204.
- Background: PubMed 29234503McNally D, Amrein K, O'Hearn K, Fergusson D, Geier P, Henderson M, Khamessan A, Lawson ML, McIntyre L, Redpath S, Weiler HA, Menon K; Canadian Critical Care Trials Group. Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study). Pilot Feasibility Stud. 2017 Dec 8;3:70. doi: 10.1186/s40814-017-0214-z. eCollection 2017.
- Background: PubMed 26762331Angurana SK. Serum Vitamin D Status and Outcome among Critically Ill Children Admitted to the Pediatric Intensive Care Unit in South India: Correspondence. Indian J Pediatr. 2016 Aug;83(8):910-1. doi: 10.1007/s12098-015-1992-z. Epub 2016 Jan 14. No abstract available.
- Background: PubMed 22869836Madden K, Feldman HA, Smith EM, Gordon CM, Keisling SM, Sullivan RM, Hollis BW, Agan AA, Randolph AG. Vitamin D deficiency in critically ill children. Pediatrics. 2012 Sep;130(3):421-8. doi: 10.1542/peds.2011-3328. Epub 2012 Aug 6.
- Background: PubMed 27419080Han JE, Jones JL, Tangpricha V, Brown MA, Brown LAS, Hao L, Hebbar G, Lee MJ, Liu S, Ziegler TR, Martin GS. High Dose Vitamin D Administration in Ventilated Intensive Care Unit Patients: A Pilot Double Blind Randomized Controlled Trial. J Clin Transl Endocrinol. 2016 Jun;4:59-65. doi: 10.1016/j.jcte.2016.04.004. Epub 2016 May 5.
- Background: PubMed 25935851Amrein K, Litonjua AA, Moromizato T, Quraishi SA, Gibbons FK, Pieber TR, Camargo CA Jr, Giovannucci E, Christopher KB. Increases in pre-hospitalization serum 25(OH)D concentrations are associated with improved 30-day mortality after hospital admission: A cohort study. Clin Nutr. 2016 Apr;35(2):514-521. doi: 10.1016/j.clnu.2015.03.020. Epub 2015 Apr 14.
- Background: PubMed 21443793Amrein K, Sourij H, Wagner G, Holl A, Pieber TR, Smolle KH, Stojakovic T, Schnedl C, Dobnig H. Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study. Crit Care. 2011;15(2):R104. doi: 10.1186/cc10120. Epub 2011 Mar 28.
- Individual participant dataSharing planned: No
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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.
Mustahsin khalil Ahmad, MBBS principal investigator
KEMU Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D and Normal saline in people with Critically Ill, run by Dr Mustahsin Khalil at 1 site in Pakistan.
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 1 inclusion and 5 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 3 Sep 2020. 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 Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Death (time frame: upto one month). The study lists 2 primary outcomes in all. 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 NCT04536831, which also lists 16 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 3 Sep 2020.