Recruiting
Phase 2

Vitamin D & HHT

Sponsor:

St. Paul's Hospital, Canada

Code:

NCT03981562

Conditions

Hereditary Haemorrhagic Telangiectasia

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Vit D

Placebo Oral Tablet

Study Details

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.

Conditions

Hereditary Haemorrhagic Telangiectasia

Study ID

NCT03981562

Start date

Jul 16, 2018

Status verified date

Jun, 2019

Completion date

Sep 1, 2020

Anticipated

Primary completion date

Jul 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1000 IU Vitamin D

experimental: 4000 IU Vitamin D

placebo comparator: Placebo

Interventions

Vit D

Patients will take an oral vitamin D supplement once a day for 6 months.

Placebo Oral Tablet

Patients will take a placebo oral tablet once a day for 6 months.

Primary outcome measure

  • Change in Epistaxis Severity Score [ Time Frame: Baseline, 3 months, and 6 months ]

Central Contacts and Locations

Central contacts

Amin Javer, MD FRCSCFARS

6048069926sinusdoc@me.com

India Dhillon, BSc

6048069926idhillon3@providencehealth.bc.ca

Locations

E.N.T Clinic, St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

India Dhillon, BSc

604-806-9926idhillon3@providencehealth.bc.ca

Principal Investigator:

Amin R Javer, MD FRCSCFARS

More Information

Sponsor

St. Paul's Hospital, Canada

Last update posted

Jun 11, 2019

Last verified

Jun, 2019

Keywords

  • Epistaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Paul's Hospital, Canada on 2019-06-11.