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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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12 December 2020 |
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Main ID: |
NCT03981562 |
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Date of registration:
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24/05/2019 |
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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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Vitamin D and Hereditary Haemorrhagic Telangiectasia
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Scientific title:
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Vitamin D Supplementation and Reduction of Severity and Frequency of Epistaxis in Hereditary Haemorrhagic Telangiectasia |
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Date of first enrolment:
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July 16, 2018 |
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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/NCT03981562 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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India Dhillon, BSc |
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Address:
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Telephone:
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604-806-9926 |
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Email:
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idhillon3@providencehealth.bc.ca |
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Affiliation:
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Name:
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Amin Javer, MD FRCSCFARS |
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Address:
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Telephone:
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6048069926 |
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Email:
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sinusdoc@me.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 19 years or older
- Definite diagnosis of HHT using the Curacao criteria;
- HHT patients already on Vitamin D supplementation (these patients will still be
included since the study is examining mega-doses specifically)
Exclusion Criteria:
- Patients with sinonasal tumours;
- Patients with bleeding disorders;
- Patients with serum levels of 250 or more ng/ml of vitamin D before or during the
study supplementation (considered to be toxic levels)
- Patients who are unable to speak English;
- Patients who live outside B.C.
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hereditary Haemorrhagic Telangiectasia
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Intervention(s)
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Drug: Vit D
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Drug: Placebo Oral Tablet
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Primary Outcome(s)
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Change in Epistaxis Severity Score
[Time Frame: Baseline, 3 months, and 6 months]
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Secondary Outcome(s)
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Change in Modified Lund-Kennedy Score
[Time Frame: Baseline, 3 months, and 6 months]
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Secondary ID(s)
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H18-01337
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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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