Allergic RhinoconjunctivitisPhase 2NCT01466465
Vitamin D and Grass Pollen Specific Immunotherapy
A Phase 2 study testing Cholecalciferol and middle-chain fatty acids (carrier) in people with Allergic Rhinoconjunctivitis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is limited by a long treatment time and high non-responder frequency. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Cholecalciferol and middle-chain fatty acids (carrier)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Jan 2015
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- written informed consent
- relative Vitamin D deficiency
- clinical relevant grass pollen allergy
- positive intradermal test with grass pollen
- forced expiratory volume at one second (FEV1) > 70%
Who cannot join
- current specific immunotherapy
- instable allergic asthma
- pregnancy and lactation
- treatment with immunomodulators or immunosuppressive drugs
- sarcoidosis, chronic diseases, malignancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM
Berlin, 10117
About this study
Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is limited by a long treatment time and high non-responder frequency. Based on experimental and epidemiological evidences we hypothesize that vitamin D can act as an effective immunomodulatory adjuvant to overcome these limitations.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Cholecalciferol, middle-chain fatty acids (carrier)
- Keywords
- Vitamin D, SIT, Grass pollen, allergic rhinoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D
given orally, once daily, before grass pollen season
middle-chain fatty acids (carrier)Other
Also called neutral oil
given orally, once daily, before grass pollen season
| Study group | Role | What they receive |
|---|---|---|
| Vigantol | Experimental | Not described Receives: Drug: Cholecalciferol |
| neutral oil (vigantol carrier) | Placebo comparator | Not described Receives: Other: middle-chain fatty acids (carrier) |
What is being measured
The primary outcome is the main question the study is designed to answer.
wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinoconjunctivitisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margitta Worm, Charite University, Berlin, Germany
- Investigators
- Worm Margitta, MD, Prof., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466465
- Sponsor's protocol ID
- ProGIT
- Other IDs
- 2010-021775-80
- Status last verified
- Jun 2015
- First submitted
- 1 Nov 2011
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Grass Pollen Specific Immunotherapy
- ClinicalTrials.gov ID
- NCT01466465
- Acronym / sponsor ID
- ProGIT
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Vitamin D, SIT, Grass pollen, allergic rhinoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Nov 2011 (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.
Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is limited by a long treatment time and high non-responder frequency. Based on experimental and epidemiological evidences we hypothesize that vitamin D can act as an effective immunomodulatory adjuvant to overcome these limitations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vigantol | Experimental | Drug: Cholecalciferol |
| neutral oil (vigantol carrier) | Placebo comparator | Other: middle-chain fatty acids (carrier) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- written informed consent
- relative Vitamin D deficiency
- clinical relevant grass pollen allergy
- positive intradermal test with grass pollen
- forced expiratory volume at one second (FEV1) > 70%
Key exclusion criteria (5 listed)
- current specific immunotherapy
- instable allergic asthma
- pregnancy and lactation
- treatment with immunomodulators or immunosuppressive drugs
- sarcoidosis, chronic diseases, malignancy
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin Dgiven orally, once daily, before grass pollen season | Drug | Vigantol |
| middle-chain fatty acids (carrier)Also: neutral oilgiven orally, once daily, before grass pollen season | Other | neutral oil (vigantol carrier) |
Primary outcome
wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo
Time frame: three years
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 25 Jun 2015.
Related trials for Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
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Allergic Asthma, Thunderstorm Asthma
RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
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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.
Worm Margitta, MD, Prof. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol and middle-chain fatty acids (carrier) in people with Allergic Rhinoconjunctivitis, run by Charite University, Berlin, Germany at 1 site in Germany.
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 5 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 25 Jun 2015. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2015.