The efficacy of the combination of allergen vaccination and vitamin D3 in the reduction of allergen-specific nasal responses. A placebo controlled trial.
| ISRCTN | ISRCTN42318360 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42318360 |
| Protocol serial number | NTR522; PG/0020 (MEC 05/204) |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funders | MedAmon B.V. i.o. (Netherlands), HALMON Laboratoria Beheer B.V. (Netherlands) |
- Submission date
- 09/01/2006
- Registration date
- 09/01/2006
- Last edited
- 25/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof W.J. Fokkens
Scientific
Scientific
Academic Medical Center
Department of Otorhinolaryngology
Room A2-234
P.O. Box 22660
Almere
1100 DD
Netherlands
| Phone | +31 (0)20 5663789 |
|---|---|
| W.J.Fokkens@amc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | VITAL |
| Study objectives | Addition of subcutaneous vitamin D3 to subcutaneous allergen vaccination offers a superior protection to allergen-induced inflammation and obstruction, in comparison to allergen vaccination alone. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Rhinitis |
| Intervention | Subcuteneous injections with: 1. Purethal grass pollen per protocol 2. Calcitriol per protocol 3. Histamine (placebo for Purethal) 4. 0.9% NaCl (placebo for Calcitriol) |
| Intervention type | Other |
| Primary outcome measure(s) |
Early reduction of allergen induced inflammation (9 weeks) measured as symptoms of sneezing, rhinorrhoea and nasal blockage after an individually standardised allergen dose (10 x and 100 x the initial threshold provocation dose) in the first hour after each allergen provocation. |
| Key secondary outcome measure(s) |
1. Airway patency measured by PNIF during the first hour and the 24 hours after allergen challenge |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | 1. Patients with rhinoconjunctivitis with or without mild asthma for at least 2 years. Their allergic symptoms should be related to the grass-pollen season. 2. A positive skin prick test for grass, minimally HEP 1 3. Positive reaction to intranasal challenge with grass-pollen 4. Age between 18 and 65 5. Patients with a written informed consent Note: Patients with concomitant sensitisation to perennial allergens like house dust mite and pets can be included as long as they do not reveal clinical symptoms or only at very rare occasional exposure. In case of sensitisation to pets, these pets should not be present at home. |
| Key exclusion criteria | 1. Use of corticosteroids (systemic and local) outside grass-pollen season (May-July) 2. Serious immunopathologic diseases or malignancies (including auto-immune diseases, tuberculosis) 3. Severe asthma or emphysema, based on questionnaire; use of inhaled corticosteroids 4. Chronic symptoms related to concomitant sensitisation to other perennial allergens like pets or mites 5. Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension 6. Diseases with a contra-indication for the use of adrenaline 7. Severe kidney disease 8. Treatment with beta-blockers or ACE inhibitors or immunosuppressive drugs 9. Severe atopic dermatitis 10. Immunotherapy (including sublingual) treatment with grass-pollen within the last 5 years 11. Pregnancy, lactation or inadequate contraceptive measures 12 Alcohol or drug abuse 13. Lack of co-operation or severe psychological disorders |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Almere
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
