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Vitamin D and Hereditary Haemorrhagic Telangiectasia

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ClinicalTrials.gov Identifier: NCT03981562
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada

Brief Summary:
The study aims to assess whether supplementing vitamin D in patients diagnosed with Hereditary Haemorrhagic Telangiectasia (HHT) will decrease the frequency and severity of nosebleeds these patients experience. It is hypothesized that the larger the dose of daily vitamin D given to the patients, the less frequent and less severe the nosebleeds will be.

Condition or disease Intervention/treatment Phase
Hereditary Haemorrhagic Telangiectasia Drug: Vit D Drug: Placebo Oral Tablet Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients included in the study will be randomized. Block randomization will be utilized to ensure an equal number of experimental and control patients are in each arm. A closed envelope system will be used to randomize participants within each arm.
Masking: Double (Participant, Investigator)
Masking Description: The study is double blinded, the investigators and the patients throughout the data collection and data analysis period will not be aware of the vitamin D dosage given.
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation and Reduction of Severity and Frequency of Epistaxis in Hereditary Haemorrhagic Telangiectasia
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 1, 2020


Arm Intervention/treatment
Experimental: 1000 IU Vitamin D Drug: Vit D
Patients will take an oral vitamin D supplement once a day for 6 months.

Experimental: 4000 IU Vitamin D Drug: Vit D
Patients will take an oral vitamin D supplement once a day for 6 months.

Placebo Comparator: Placebo Drug: Placebo Oral Tablet
Patients will take a placebo oral tablet once a day for 6 months.




Primary Outcome Measures :
  1. Change in Epistaxis Severity Score [ Time Frame: Baseline, 3 months, and 6 months ]

    A questionnaire that will be given to the patients at each visit which is a major predictor of quality of life in HHT patients.

    The score includes six independent predictors of self-described epistaxis severity. The responses will then be weighted by respective coefficients and these added together to give a raw ESS, which will then be divided by the range of the raw score (2.71) and multiplied by 10 to give normalized ESS within the range of 0 to 10 (no epistaxis to severe epistaxis).



Secondary Outcome Measures :
  1. Change in Modified Lund-Kennedy Score [ Time Frame: Baseline, 3 months, and 6 months ]
    The score is an objective measure based on Endoscopic sinonasal mucosal inflammation. The score is determined from a range of 0-12 with higher numbers indicating worse inflammation. Endoscopy will determine the density and location of telangiectasias, vascular morphology or patterns, relative percentage of arteriovenous malformations (AVMs), degree of crusting, septal perforation and site.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981562


Contacts
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Contact: Amin Javer, MD FRCSCFARS 6048069926 sinusdoc@me.com
Contact: India Dhillon, BSc 6048069926 idhillon3@providencehealth.bc.ca

Locations
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Canada, British Columbia
E.N.T Clinic, St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: India Dhillon, BSc    604-806-9926    idhillon3@providencehealth.bc.ca   
Principal Investigator: Amin R Javer, MD FRCSCFARS         
Sponsors and Collaborators
St. Paul's Hospital, Canada

Additional Information:
Publications:

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Responsible Party: Amin Javer, Director, St. Paul's Sinus Centre, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT03981562     History of Changes
Other Study ID Numbers: H18-01337
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication will be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amin Javer, St. Paul's Hospital, Canada:
Epistaxis
Additional relevant MeSH terms:
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Telangiectasia, Hereditary Hemorrhagic
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Telangiectasis
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents