Condition category
Respiratory
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof W.J. Fokkens

ORCID ID

Contact details

Academic Medical Center
Department of Otorhinolaryngology
Room A2-234
P.O. Box 22660
Almere
1100 DD
Netherlands
+31 (0)20 5663789
W.J.Fokkens@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR522; PG/0020 (MEC 05/204)

Study information

Scientific title

Acronym

VITAL

Study hypothesis

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

Received from local medical ethics committee

Study design

Multicentre randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

1. Airway patency measured by PNIF during the first hour and the 24 hours after allergen challenge
2. Nasal symptom score for 24 hours after nasal allergen challenge
3. ECP/albumin ratio and cytokines (IL5, IL10) in nasal lavage
4. Clinical index score (CIS) during the grass-pollen season 2006

Overall trial start date

01/12/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant 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

Recruitment start date

01/12/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Almere
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Otorhinolaryngology
P.O. Box 22660
Almere
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

MedAmon B.V. i.o. (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

HALMON Laboratoria Beheer B.V. (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes