BronchiolitisPhase 2/3NCT05795933
Efficacy of Vitamin D Supplementation for Children With Bronchiolitis
A Phase 2/3 study testing Vitamin D3 in people with Bronchiolitis, run by Sohag University at 1 site in Egypt.
Trial summary
Vitamin D plays an important role in enhancing mucosal immune defense, decreasing excessive inflammation, and increasing mucociliary clearance. Experimental studies have shown that vitamin D reduces inflammation of epithelial cells in airways infected with Respiratory Syncytial Virus and confers antiviral effects. Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 14 Jul 2024
- Phase
- Phase 2/3
- 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 3 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 3 to 24 months.
- Clinical diagnosis of first episode of bronchiolitis
- First 24 hours of admission.
- Stable or decreasing requirement for oxygen on 2 measurements 2 hours apart.
- Pulse rate less than 180 beat/minute.
- Respiratory rate less than 80 breath/min.
- Oxygen supplementation < 40% Fraction of inspired oxygen or < 2 L/min by nasal prong
- Not on high flow nasal cannula, continuous positive airway pressure, or mechanical ventilation at the time of enrollment.
Who cannot join
- .• History of previous episodes of wheezing.
- History of apnea
- Need for positive pressure support or high flow nasal cannula at the time of enrollment.
- Chronic lung disease (requiring home oxygen, or pulmonary hypertension)
- Cardiac disease (cyanotic, hemodynamically significant [requiring diuretics], or pulmonary hypertension).
- Neuromuscular disease.
Show all 14Show fewer
- Metabolic disease.
- Immunodeficiency.
- Chromosomal abnormalities.
- Craniofacial malformation
- Hemoglobinopathy.
- Hypercalcemia
- Chromosomal abnormalities
- Use of large doses of vitamin D (> 400 IU/day) in the last month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Vitamin D Supplementation for Children With Bronchiolitis at Sohag University Hospital
Vitamin D plays an important role in enhancing mucosal immune defense, decreasing excessive inflammation, and increasing mucociliary clearance. Experimental studies have shown that vitamin D reduces inflammation of epithelial cells in airways infected with Respiratory Syncytial Virus and confers antiviral effects. Furthermore, several studies have shown lower serum vitamin D levels in hospitalized children with bronchiolitis. However, studies on the efficacy of Vitamin D supplementation for children with bronchiolitis are scarce with inconsistent findings. In this study, we aim to evaluate the efficacy of vitamin D supplementation in children with bronchiolitis.
Read the detailed description
Bronchiolitis is the most frequent lower respiratory tract infection in children under two years of age, which represents a major cause of medical visits, hospital admissions, and death. This disease predominantly affects small airways with acute inflammatory edema epithelial cells, excess mucus production, and bronchospasm. The most commonly involved organisms are Respiratory Syncytial Virus (accounting for 60% of cases), followed by Rhinovirus, Parainfluenza, Metapneumovirus, Influenza, and Adenovirus. Certain factors are associated with a higher risk of severe bronchiolitis, such as prematurity, chronic lung disease, cardiac disease, immunodeficiency, neuromuscular disease, and Down syndrome.
Diagnosis of bronchiolitis relies on a constellation of clinical manifestations, including respiratory distress and wheezing preceded by viral upper respiratory tract prodrome in children under two years of age. Common manifestations of bronchiolitis are rhinorrhea, cough, wheezing, tachypnea, and increased work of breathing, including nasal flaring, retractions, and grunting. Management of bronchiolitis is mainly supportive, aiming at maintaining adequate oxygenation and hydration.
Given the high burden of bronchiolitis and the lack of specific treatment, studies have investigated several therapeutic options. One of these potential therapies is vitamin D. Vitamin D is a fat-soluble vitamin that is mainly formed in the skin after exposure to ultraviolet rays, while less than 10% is obtained from dietary sources. Besides regulation of calcium and phosphorus homeostasis, vitamin D plays an important role in enhancing mucosal immune defense, decreasing excessive inflammation, and increasing mucociliary clearance. Vitamin D deficiency is common among children, particularly in developing countries, and has been linked to an increased risk of several diseases, including bronchiolitis, pneumonia, and otitis media.
Experimental studies have shown that vitamin D reduces inflammation of epithelial cells in airways infected with Respiratory Syncytial Virus and confers antiviral effects. Furthermore, several studies have shown lower serum vitamin D levels in hospitalized children with bronchiolitis. However, studies on the efficacy of Vitamin D supplementation for children with bronchiolitis are scarce with inconsistent findings.
In this study, we aim to evaluate the efficacy of vitamin D supplementation in children with bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- Vitamin D3
- Keywords
- Bronchiolitis, Vitamin D, Children
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Cholecalciferol, Devarol
A single dose of intramuscular 200,000 IU vitamin D3 within 24 hours of admission
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Children receive a single dose of intramuscular 200,000 IU vitamin D3 Receives: Drug: Vitamin D3 |
| Control group | No intervention | Children receiving only the standard recommended dose of vitamin D3 as 400 IU/day orally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to discharge
Time from randomization to hospital discharge (in hours)
Measured: 4 weeks
Secondary outcomes (11)
Time from randomization to discontinuation of oxygen therapy
Time from randomization to discontinuation of oxygen therapy (in hours)
Measured: 4 weeks
Time from randomization to discontinuation of intravenous fluids
Time from randomization to discontinuation of intravenous fluids (in hours)
Measured: 4 weeks
Time from randomization to meeting discharge criteria
Time from randomization to meeting hospital discharge criteria (in hours)
Measured: 4 weeks
Time from hospital admission to discharge
Time from hospital admission to discharge (in hours)
Measured: 4 weeks
Blood level of 25-hydroxycholecalciferol
Blood level of 25-hydroxycholecalciferol
Measured: On day 3 after randomization
Serum level of ionized calcium
Serum level of ionized calcium
Measured: On day 3 after randomization
Admission to pediatric intensive care unit
Proportion of patients admitted to pediatric intensive care unit
Measured: 4 weeks
Intubation
Proportion of patients who underwent endotracheal intubation
Measured: 4 weeks
Mortality
Proportion of patients who died during hospital admission
Measured: 4 weeks
Bronchodilator therapy
Proportion of patients who received bronchodilator therapy
Measured: 4 weeks
Systemic steroids
Proportion of patients who received systemic steroids
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Apr 2023
- Primary completion22 Jun 2024
- Study completion14 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of children with bronchiolitis: Study group: will receive a single dose of intramuscular 200,000 IU vitamin D3 within 24 hours of admission. Control group: will receive the standard recommended dose of vitamin D3 as 400 IU/day orally
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youstina Safwat Labib, Sohag University
- Investigators
- Mostafa A Mohammed, MD, PhD, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795933
- Sponsor's protocol ID
- Soh-Med-23-03-11MS
- Status last verified
- Oct 2024
- First submitted
- 8 Mar 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified patients' data will be available upon reasonable request after publication
Publications
Manti S, Staiano A, Orfeo L, Midulla F, Marseglia GL, Ghizzi C, Zampogna S, Carnielli VP, Favilli S, Ruggieri M, Perri D, Di Mauro G, Gattinara GC, D'Avino A, Becherucci P, Prete A, Zampino G, Lanari M, Biban P, Manzoni P, Esposito S, Corsello G, Baraldi E. UPDATE - 2022 Italian guidelines on the management of bronchiolitis in infants. Ital J Pediatr. 2023 Feb 10;49(1):19. doi: 10.1186/s13052-022-01392-6.
PubMed 36765418Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
PubMed 25349312Munns CF, Shaw N, Kiely M, Specker BL, Thacher TD, Ozono K, Michigami T, Tiosano D, Mughal MZ, Makitie O, Ramos-Abad L, Ward L, DiMeglio LA, Atapattu N, Cassinelli H, Braegger C, Pettifor JM, Seth A, Idris HW, Bhatia V, Fu J, Goldberg G, Savendahl L, Khadgawat R, Pludowski P, Maddock J, Hypponen E, Oduwole A, Frew E, Aguiar M, Tulchinsky T, Butler G, Hogler W. Global Consensus Recommendations on Prevention and Management of Nutritional Rickets. J Clin Endocrinol Metab. 2016 Feb;101(2):394-415. doi: 10.1210/jc.2015-2175. Epub 2016 Jan 8.
PubMed 26745253Esposito S, Lelii M. Vitamin D and respiratory tract infections in childhood. BMC Infect Dis. 2015 Oct 28;15:487. doi: 10.1186/s12879-015-1196-1.
PubMed 26521023Golan-Tripto I, Loewenthal N, Tal A, Dizitzer Y, Baumfeld Y, Goldbart A. Vitamin D deficiency in children with acute bronchiolitis: a prospective cross-sectional case- control study. BMC Pediatr. 2021 Apr 30;21(1):211. doi: 10.1186/s12887-021-02666-4.
PubMed 33931018Khoshnevisasl P, Sadeghzadeh M, Kamali K, Ardalani A. A randomized clinical trial to assess the effect of zinc and vitamin D supplementation in addition to hypertonic saline on treatment of acute bronchiolitis. BMC Infect Dis. 2022 Jun 13;22(1):538. doi: 10.1186/s12879-022-07492-2.
PubMed 35692038Wang EE, Milner RA, Navas L, Maj H. Observer agreement for respiratory signs and oximetry in infants hospitalized with lower respiratory infections. Am Rev Respir Dis. 1992 Jan;145(1):106-9. doi: 10.1164/ajrccm/145.1.106.
PubMed 1731571Brustad N, Yousef S, Stokholm J, Bonnelykke K, Bisgaard H, Chawes BL. Safety of High-Dose Vitamin D Supplementation Among Children Aged 0 to 6 Years: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Apr 1;5(4):e227410. doi: 10.1001/jamanetworkopen.2022.7410.
PubMed 35420658Sarhan AA, Saeed NM, Mostafa AA, Osman AM. Vitamin D supplementation for acute bronchiolitis: a double-blind randomized controlled trial. Alexandria Journal of Pediatrics. 2019;32(2):61.
Saad K, Abd Aziz NH, El-Houfey AA, El-Asheer O, Mohamed SA, Ahmed AE, Abdel Baseer KA, Darwish MM. Trial of vitamin D supplementation in infants with bronchiolitis: a randomized, double-blind, placebo-controlled study. Pediatric Allergy, Immunology, and Pulmonology. 2015;28(2):102-6
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vitamin D Supplementation for Children With Bronchiolitis at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05795933
- Acronym / sponsor ID
- Soh-Med-23-03-11MS
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, Vitamin D, Children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 22 Jun 2024 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 3 Apr 2023 (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 plays an important role in enhancing mucosal immune defense, decreasing excessive inflammation, and increasing mucociliary clearance. Experimental studies have shown that vitamin D reduces inflammation of epithelial cells in airways infected with Respiratory Syncytial Virus and confers antiviral effects. Furthermore, several studies have shown lower serum vitamin D levels in hospitalized children with bronchiolitis. However, studies on the efficacy of Vitamin D supplementation for children with bronchiolitis are scarce with inconsistent findings. In this study, we aim to evaluate the efficacy of vitamin D supplementation in children with bronchiolitis.
Detailed description
Bronchiolitis is the most frequent lower respiratory tract infection in children under two years of age, which represents a major cause of medical visits, hospital admissions, and death. This disease predominantly affects small airways with acute inflammatory edema epithelial cells, excess mucus production, and bronchospasm. The most commonly involved organisms are Respiratory Syncytial Virus (accounting for 60% of cases), followed by Rhinovirus, Parainfluenza, Metapneumovirus, Influenza, and Adenovirus. Certain factors are associated with a higher risk of severe bronchiolitis, such as prematurity, chronic lung disease, cardiac disease, immunodeficiency, neuromuscular disease, and Down syndrome.
Diagnosis of bronchiolitis relies on a constellation of clinical manifestations, including respiratory distress and wheezing preceded by viral upper respiratory tract prodrome in children under two years of age. Common manifestations of bronchiolitis are rhinorrhea, cough, wheezing, tachypnea, and increased work of breathing, including nasal flaring, retractions, and grunting. Management of bronchiolitis is mainly supportive, aiming at maintaining adequate oxygenation and hydration.
Given the high burden of bronchiolitis and the lack of specific treatment, studies have investigated several therapeutic options. One of these potential therapies is vitamin D. Vitamin D is a fat-soluble vitamin that is mainly formed in the skin after exposure to ultraviolet rays, while less than 10% is obtained from dietary sources. Besides regulation of calcium and phosphorus homeostasis, vitamin D plays an important role in enhancing mucosal immune defense, decreasing excessive inflammation, and increasing mucociliary clearance. Vitamin D deficiency is common among children, particularly in developing countries, and has been linked to an increased risk of several diseases, including bronchiolitis, pneumonia, and otitis media.
Experimental studies have shown that vitamin D reduces inflammation of epithelial cells in airways infected with Respiratory Syncytial Virus and confers antiviral effects. Furthermore, several studies have shown lower serum vitamin D levels in hospitalized children with bronchiolitis. However, studies on the efficacy of Vitamin D supplementation for children with bronchiolitis are scarce with inconsistent findings.
In this study, we aim to evaluate the efficacy of vitamin D supplementation in children with bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of children with bronchiolitis: Study group: will receive a single dose of intramuscular 200,000 IU vitamin D3 within 24 hours of admission. Control group: will receive the standard recommended dose of vitamin D3 as 400 IU/day orally
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Vitamin D3Children receive a single dose of intramuscular 200,000 IU vitamin D3 |
| Control group | No intervention | –Children receiving only the standard recommended dose of vitamin D3 as 400 IU/day orally |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age between 3 to 24 months.
- Clinical diagnosis of first episode of bronchiolitis
- First 24 hours of admission.
- Stable or decreasing requirement for oxygen on 2 measurements 2 hours apart.
- Pulse rate less than 180 beat/minute.
Key exclusion criteria (14 listed)
- .• History of previous episodes of wheezing.
- History of apnea
- Need for positive pressure support or high flow nasal cannula at the time of enrollment.
- Chronic lung disease (requiring home oxygen, or pulmonary hypertension)
- Cardiac disease (cyanotic, hemodynamically significant [requiring diuretics], or pulmonary hypertension).
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 D3Also: Cholecalciferol, DevarolA single dose of intramuscular 200,000 IU vitamin D3 within 24 hours of admission | Drug | Study group |
Primary outcome
Time from randomization to discharge
Time frame: 4 weeks
Time from randomization to hospital discharge (in hours)
11 secondary outcomes
Time from randomization to discontinuation of oxygen therapy
Time frame: 4 weeks
Time from randomization to discontinuation of intravenous fluids
Time frame: 4 weeks
Time from randomization to meeting discharge criteria
Time frame: 4 weeks
Time from hospital admission to discharge
Time frame: 4 weeks
Blood level of 25-hydroxycholecalciferol
Time frame: On day 3 after randomization
Serum level of ionized calcium
Time frame: On day 3 after randomization
Admission to pediatric intensive care unit
Time frame: 4 weeks
Intubation
Time frame: 4 weeks
Mortality
Time frame: 4 weeks
Bronchodilator therapy
Time frame: 4 weeks
Systemic steroids
Time frame: 4 weeks
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 29 Oct 2024.
- Background: PubMed 36765418Manti S, Staiano A, Orfeo L, Midulla F, Marseglia GL, Ghizzi C, Zampogna S, Carnielli VP, Favilli S, Ruggieri M, Perri D, Di Mauro G, Gattinara GC, D'Avino A, Becherucci P, Prete A, Zampino G, Lanari M, Biban P, Manzoni P, Esposito S, Corsello G, Baraldi E. UPDATE - 2022 Italian guidelines on the management of bronchiolitis in infants. Ital J Pediatr. 2023 Feb 10;49(1):19. doi: 10.1186/s13052-022-01392-6.
- Background: PubMed 25349312Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
- Background: PubMed 26745253Munns CF, Shaw N, Kiely M, Specker BL, Thacher TD, Ozono K, Michigami T, Tiosano D, Mughal MZ, Makitie O, Ramos-Abad L, Ward L, DiMeglio LA, Atapattu N, Cassinelli H, Braegger C, Pettifor JM, Seth A, Idris HW, Bhatia V, Fu J, Goldberg G, Savendahl L, Khadgawat R, Pludowski P, Maddock J, Hypponen E, Oduwole A, Frew E, Aguiar M, Tulchinsky T, Butler G, Hogler W. Global Consensus Recommendations on Prevention and Management of Nutritional Rickets. J Clin Endocrinol Metab. 2016 Feb;101(2):394-415. doi: 10.1210/jc.2015-2175. Epub 2016 Jan 8.
- Background: PubMed 26521023Esposito S, Lelii M. Vitamin D and respiratory tract infections in childhood. BMC Infect Dis. 2015 Oct 28;15:487. doi: 10.1186/s12879-015-1196-1.
- Background: PubMed 33931018Golan-Tripto I, Loewenthal N, Tal A, Dizitzer Y, Baumfeld Y, Goldbart A. Vitamin D deficiency in children with acute bronchiolitis: a prospective cross-sectional case- control study. BMC Pediatr. 2021 Apr 30;21(1):211. doi: 10.1186/s12887-021-02666-4.
- Background: PubMed 35692038Khoshnevisasl P, Sadeghzadeh M, Kamali K, Ardalani A. A randomized clinical trial to assess the effect of zinc and vitamin D supplementation in addition to hypertonic saline on treatment of acute bronchiolitis. BMC Infect Dis. 2022 Jun 13;22(1):538. doi: 10.1186/s12879-022-07492-2.
- Background: PubMed 1731571Wang EE, Milner RA, Navas L, Maj H. Observer agreement for respiratory signs and oximetry in infants hospitalized with lower respiratory infections. Am Rev Respir Dis. 1992 Jan;145(1):106-9. doi: 10.1164/ajrccm/145.1.106.
- Background: PubMed 35420658Brustad N, Yousef S, Stokholm J, Bonnelykke K, Bisgaard H, Chawes BL. Safety of High-Dose Vitamin D Supplementation Among Children Aged 0 to 6 Years: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Apr 1;5(4):e227410. doi: 10.1001/jamanetworkopen.2022.7410.
- BackgroundSarhan AA, Saeed NM, Mostafa AA, Osman AM. Vitamin D supplementation for acute bronchiolitis: a double-blind randomized controlled trial. Alexandria Journal of Pediatrics. 2019;32(2):61.
- BackgroundSaad K, Abd Aziz NH, El-Houfey AA, El-Asheer O, Mohamed SA, Ahmed AE, Abdel Baseer KA, Darwish MM. Trial of vitamin D supplementation in infants with bronchiolitis: a randomized, double-blind, placebo-controlled study. Pediatric Allergy, Immunology, and Pulmonology. 2015;28(2):102-6
- Individual participant dataSharing planned: Yes. Unidentified patients' data will be available upon reasonable request after publication
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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.
Mostafa A Mohammed, MD, PhD study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin D3 in people with Bronchiolitis, run by Sohag University at 1 site in Egypt.
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 8 inclusion and 14 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 29 Oct 2024. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time from randomization to discharge (time frame: 4 weeks). 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 NCT05795933, which also lists 10 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 29 Oct 2024.