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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2016 |
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Main ID: |
NCT02738619 |
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Date of registration:
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06/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Allergic Rhinitis, Immunotherapy and Vitamin d
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Scientific title:
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Vitamin D Supplementation as an Adjuvant Therapy for Specific Immunotherapy in Patients With Allergic Rhinitis. |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02738619 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Mexico
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Contacts
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Name:
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JUAN CARLOS FERNANDEZ DE CORDOVA AGUIRRE |
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Address:
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Telephone:
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015551043578 |
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Email:
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drjuanfdcordova@gmail.com |
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Affiliation:
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Name:
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juan c fernandez de cordova, md |
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Address:
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Telephone:
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5551043578 |
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Email:
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drjuanfdcordova@gmail.com |
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Affiliation:
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Name:
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joselin hernandez, dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital General de Mexico |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients female and male of 5-13 years diagnosed with persistent allergic rhinitis
according to ARIA guide
2. To sign the consent and legal representatives informed consent and patient.
3. Being sensitized to a aeroallergen and are candidates for specific immunotherapy.
4. Let them bring serum levels of 25 (OH) D less than 30 ng / ml
5. are in Stage 1 or 2 Tanner.
6. BMI within the normal range (between 5 and 85 percentiles)
Exclusion Criteria:
1. primary and / or secondary immunodeficiencies
2. Chronic nasal polyposis
3. Adenoiditis and / or tonsillitis candidates for surgical resolution
4. have taken vitamin D in the last 6 months.
5. have used specific allergen immunotherapy in the last 5 years.
Age minimum:
3 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Allergy
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Intervention(s)
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Drug: placebo
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Drug: Vitamin D3
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Primary Outcome(s)
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Rhino-conjunctivitis Questionnaire (symptom severity)
[Time Frame: Time Frame: 3 months after intervention]
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Rhino-conjunctivitis Questionnaire (symptom severity)
[Time Frame: Time Frame: Baseline]
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Secondary ID(s)
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DI/15/309/04/042
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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