Vitamin D Deficiency, Nasal PolyposisPhase 1NCT04529668
Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis
A Phase 1 study testing vitamin D supplementation and usual therapy for nasal polyposis in people with Vitamin D Deficiency, Nasal Polyposis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Aim of the work 1. To determine if chronic rhinosinusitis with nasal polyps' (CRSwNP) populations are vitamin D deficient. 2. To determine the possible anti-inflammatory effect of vitamin D supplementation (clinically \& histologically). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitamin D Deficiency, Nasal Polyposis
- What is being tested?
- vitamin D supplementation and usual therapy for nasal polyposis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2015to 20 Oct 2020
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients (18-60) years of age with clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) at Otorhinolaryngology outpatient clinic, Ain Shams University hospital.
Who cannot join
- • Pregnant and lactating females.
- Patients taking multivitamins containing vitamin D for at least six months.
- Immune deficiency or suppression.
- Ciliary motility disorders.
- Wegner's granulomatosis and other granulomatous diseases.
- Sino-nasal malignancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams Univesrity
Cairo
Fatma S Ebeid, MD, +20109556 9596, dr.fatma_ebeid@yahoo.com
About this study
Official title: Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis: Clinical, Laboratory & Immunohistochemical Study
Aim of the work
- To determine if chronic rhinosinusitis with nasal polyps' (CRSwNP) populations are vitamin D deficient.
- To determine the possible anti-inflammatory effect of vitamin D supplementation (clinically \& histologically). \& investigate its relation to immunohistochemical tissue expression of basic fibroblast growth factor
Read the detailed description
Patients \& methods
Study groups:
Fifty patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) resistant to medical treatment at Otorhinolaryngology outpatient clinic, Ain Shams University hospitals. Group I : twenty five patients will receive vitamin D supplementation, while group II won't receive vitamin D supplementation.
Inclusion criteria:
Patients (18-60) years of age with clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) resistant to medical treatment at Otorhinolaryngology outpatient clinic, Ain Shams University hospital.
Both groups (I \& II) will be subjected to venous blood sampling and 25(OH) vitamin D level measurement \& will be subjected to:
- Careful history taking.
- Complete ENT examination and endoscopic evaluation of the nose.
- CT scan paranasal sinuses coronal and axial view to evaluate the affected sinuses.
- Vitamin D3 serum level (before Vitamin D3 supplementation).
- Biopsy from nasal polyps \& immunohistochemical assessment (before Vitamin D3 supplementation).
- Vitamin D3 supplementation 50000 IU/weekly for 6 weeks.
- Vitamin D3 serum level (after Vitamin D3 supplementation).
- Biopsy from nasal polyps \& immunohistochemical assessment (after Vitamin D3 supplementation).
Exclusion criteria:
- Pregnant and lactating females.
- Patients taking multivitamins containing vitamin D for at least six months.
- Immune deficiency or suppression.
- Ciliary motility disorders.
- Wegner's granulomatosis and other granulomatous diseases.
- Sino-nasal malignancy.
- History:
- Personal history: name, age, sex, occupation and environment (smoking, exposure to irritants).
- Complaint and history of present illness: analysis of the patient's chief complaints with special emphasis on CRS symptoms.
- Medical history: Previous medical treatment for CRS (antibiotics, topical and systemic corticosteroids, etc...) or for any other disease (allergy, hypertension, asthma, GERD, etc...) including questions about the dose and duration of treatment and the achieved results. It included also past history of surgery.
- Family history: History of allergy, asthma, polyposis, migraine, genetic diseases, etc….
- Examination:
- General examination: it will be done for all patients as a routine.
- Local examination (complete ENT examination): Oral, laryngeal and ear examination will be done to exclude other ENT disease and then careful nasal examination will be done.
- Endoscopic examination: Diagnostic nasal endoscopy will be done for all patients.
- Investigations: A- CT scans will be done (in coronal, axial planes) for all patients with chronic rhinosinusitis with nasal Polyposis (CRSwNP). B- 25-OH Vitamin D serum level: (before \& after vitamin D supplementation)
- Biopsy from nasal polyps : Tissue samples will be taken from the nasal polyps of all patients with chronic rhinosinusitis with nasal Polyposis (CRSwNP) at the start of the study (before VD therapy) under local anesthesia at the outpatient clinic for histological (epithelium, basal lamina, lamina propria, cells, blood vessels) \& immunohistochemical (basic fibroblast growth factors) examination.
- Vitamin D3 supplementation: Vitamin D3 (cholecalciferol) will be given to the study group Ia orally 50000 IU weekly for 6 weeks. In addition to local nasal steroids \& saline nasal wash. All patients will be monitored by serum calcium level. While group Ib will not be given vitamin D supplementation.
- Biopsy from nasal polyps :
Tissue samples will be taken from the nasal polyps of all patients with chronic rhinosinusitis with nasal Polyposis (CRSwNP) after vitamin D supplementation for immunohistochemical assessment.
- Conditions
- Vitamin D Deficiency, Nasal Polyposis
- Being tested
- vitamin D supplementation, usual therapy for nasal polyposis
- Keywords
- VITAMIN D DEFICIENCY, CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS
- Medical subject headings
- Vitamin D Deficiency, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D supplementationDrug
vitamin D supplementation
usual therapy for nasal polyposisDrug
steroids ( systemic and local )
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will receive vitamin D supplementation Receives: Drug: vitamin D supplementation |
| group II | Active comparator | twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will NOT receive vitamin D supplementation Receives: Drug: usual therapy for nasal polyposis |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient complaint
by SNOT-22 , Sino-nasal Outcome Test , completion of the SNOT-22 prior to and following Vitamin D supplementation . Each subject completed the SNOT-22 during a clinic visit by answering all questions based on a 0-5 scale, where 0 defines no problems with the given symptom and 5 defines maximal problems
Measured: 6 weeks
examintaion
Lund \& Kennedy endoscopic appearance score, examination will be done before and after vitamin D supplementation , with 0 means absent finding and 2 means worst finding
Measured: 6 weeks
histopathology
immunohistochemitsry for fibroblast growth factor
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Oct 2015
- Primary completion1 Oct 2020 (estimated)
- Study completion20 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D Deficiency, Nasal PolyposisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Salah Mohammad Mahmoud, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529668
- Sponsor's protocol ID
- FMASUMD241/2015
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.
PubMed 22469599
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis: Clinical, Laboratory & Immunohistochemical Study
- ClinicalTrials.gov ID
- NCT04529668
- Acronym / sponsor ID
- FMASUMD241/2015
- Conditions
- Vitamin D Deficiency, Nasal Polyposis
- Keywords
- VITAMIN D DEFICIENCY, CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 20 Oct 2020 (estimated)
- First posted
- 27 Aug 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.
Aim of the work
- To determine if chronic rhinosinusitis with nasal polyps' (CRSwNP) populations are vitamin D deficient.
- To determine the possible anti-inflammatory effect of vitamin D supplementation (clinically \& histologically). \& investigate its relation to immunohistochemical tissue expression of basic fibroblast growth factor
Detailed description
Patients \& methods
Study groups:
Fifty patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) resistant to medical treatment at Otorhinolaryngology outpatient clinic, Ain Shams University hospitals. Group I : twenty five patients will receive vitamin D supplementation, while group II won't receive vitamin D supplementation.
Inclusion criteria:
Patients (18-60) years of age with clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) resistant to medical treatment at Otorhinolaryngology outpatient clinic, Ain Shams University hospital.
Both groups (I \& II) will be subjected to venous blood sampling and 25(OH) vitamin D level measurement \& will be subjected to:
- Careful history taking.
- Complete ENT examination and endoscopic evaluation of the nose.
- CT scan paranasal sinuses coronal and axial view to evaluate the affected sinuses.
- Vitamin D3 serum level (before Vitamin D3 supplementation).
- Biopsy from nasal polyps \& immunohistochemical assessment (before Vitamin D3 supplementation).
- Vitamin D3 supplementation 50000 IU/weekly for 6 weeks.
- Vitamin D3 serum level (after Vitamin D3 supplementation).
- Biopsy from nasal polyps \& immunohistochemical assessment (after Vitamin D3 supplementation).
Exclusion criteria:
- Pregnant and lactating females.
- Patients taking multivitamins containing vitamin D for at least six months.
- Immune deficiency or suppression.
- Ciliary motility disorders.
- Wegner's granulomatosis and other granulomatous diseases.
- Sino-nasal malignancy.
- History:
- Personal history: name, age, sex, occupation and environment (smoking, exposure to irritants).
- Complaint and history of present illness: analysis of the patient's chief complaints with special emphasis on CRS symptoms.
- Medical history: Previous medical treatment for CRS (antibiotics, topical and systemic corticosteroids, etc...) or for any other disease (allergy, hypertension, asthma, GERD, etc...) including questions about the dose and duration of treatment and the achieved results. It included also past history of surgery.
- Family history: History of allergy, asthma, polyposis, migraine, genetic diseases, etc….
- Examination:
- General examination: it will be done for all patients as a routine.
- Local examination (complete ENT examination): Oral, laryngeal and ear examination will be done to exclude other ENT disease and then careful nasal examination will be done.
- Endoscopic examination: Diagnostic nasal endoscopy will be done for all patients.
- Investigations: A- CT scans will be done (in coronal, axial planes) for all patients with chronic rhinosinusitis with nasal Polyposis (CRSwNP). B- 25-OH Vitamin D serum level: (before \& after vitamin D supplementation)
- Biopsy from nasal polyps : Tissue samples will be taken from the nasal polyps of all patients with chronic rhinosinusitis with nasal Polyposis (CRSwNP) at the start of the study (before VD therapy) under local anesthesia at the outpatient clinic for histological (epithelium, basal lamina, lamina propria, cells, blood vessels) \& immunohistochemical (basic fibroblast growth factors) examination.
- Vitamin D3 supplementation: Vitamin D3 (cholecalciferol) will be given to the study group Ia orally 50000 IU weekly for 6 weeks. In addition to local nasal steroids \& saline nasal wash. All patients will be monitored by serum calcium level. While group Ib will not be given vitamin D supplementation.
- Biopsy from nasal polyps :
Tissue samples will be taken from the nasal polyps of all patients with chronic rhinosinusitis with nasal Polyposis (CRSwNP) after vitamin D supplementation for immunohistochemical assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Drug: vitamin D supplementationtwenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will receive vitamin D supplementation |
| group II | Active comparator | Drug: usual therapy for nasal polyposistwenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will NOT receive vitamin D supplementation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients (18-60) years of age with clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) at Otorhinolaryngology outpatient clinic, Ain Shams University hospital.
Key exclusion criteria (6 listed)
- • Pregnant and lactating females.
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 D supplementationvitamin D supplementation | Drug | group I |
| usual therapy for nasal polyposissteroids ( systemic and local ) | Drug | group II |
Primary outcome
patient complaint
Time frame: 6 weeks
by SNOT-22 , Sino-nasal Outcome Test , completion of the SNOT-22 prior to and following Vitamin D supplementation . Each subject completed the SNOT-22 during a clinic visit by answering all questions based on a 0-5 scale, where 0 defines no problems with the given symptom and 5 defines maximal problems
examintaion
Time frame: 6 weeks
Lund \& Kennedy endoscopic appearance score, examination will be done before and after vitamin D supplementation , with 0 means absent finding and 2 means worst finding
histopathology
Time frame: 6 weeks
immunohistochemitsry for fibroblast growth factor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Results publication: PubMed 22469599Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vitamin D supplementation and usual therapy for nasal polyposis in people with Vitamin D Deficiency, Nasal Polyposis, run by Ain Shams 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 1 inclusion and 6 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 31 Aug 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 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Fatma S Ebeid, MD (+20109556 9596, dr.fatma_ebeid@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient complaint (time frame: 6 weeks). The study lists 3 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 NCT04529668, which also lists 1 linked publication.
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 31 Aug 2020.