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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Ain shams Univesrity

    Cairo

    Fatma S Ebeid, MD, +20109556 9596, dr.fatma_ebeid@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis: Clinical, Laboratory & Immunohistochemical Study

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). \& 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:

  1. Careful history taking.
  2. Complete ENT examination and endoscopic evaluation of the nose.
  3. CT scan paranasal sinuses coronal and axial view to evaluate the affected sinuses.
  4. Vitamin D3 serum level (before Vitamin D3 supplementation).
  5. Biopsy from nasal polyps \& immunohistochemical assessment (before Vitamin D3 supplementation).
  6. Vitamin D3 supplementation 50000 IU/weekly for 6 weeks.
  7. Vitamin D3 serum level (after Vitamin D3 supplementation).
  8. 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.
  1. History:
  2. Personal history: name, age, sex, occupation and environment (smoking, exposure to irritants).
  3. Complaint and history of present illness: analysis of the patient's chief complaints with special emphasis on CRS symptoms.
  4. 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.
  5. Family history: History of allergy, asthma, polyposis, migraine, genetic diseases, etc….
  6. Examination:
  7. General examination: it will be done for all patients as a routine.
  8. 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.
  9. Endoscopic examination: Diagnostic nasal endoscopy will be done for all patients.
  10. 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)
  11. 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.
  12. 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.
  13. 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.

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 groups in NCT04529668
Study groupRoleWhat they receive
group IExperimentaltwenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will receive vitamin D supplementation
Receives: Drug: vitamin D supplementation
group IIActive comparatortwenty-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.

  1. 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

  2. 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

  3. 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.

  1. First posted27 Aug 2020
  2. Study start1 Oct 2015
  3. Primary completion1 Oct 2020 (estimated)
  4. Study completion20 Oct 2020 (estimated)

Resources

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)
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

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.

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