Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis (NCT04496921) | Clinical Trial Compass
WithdrawnNot Applicable
Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis
Stopped: Clinical care of patients with CF changed following COVID-19 pandemic (OGTT not performed at the CF clinic since March 2020); in consequence, this study is no longer feasible.
Canada0Started 2020-08-10
Plain-language summary
Cystic fibrosis (CF) patients are at risk for vitamin K deficiencies. Supplementation for fat-soluble vitamins A, D, and E is well established, but in CF, there is little data for vitamin K concerning the optimal dose and frequency of supplementation. Beyond its known role in coagulation, research has highlighted the role of vitamin K for bone health and the control of blood sugar levels. However, after pulmonary complications, the risk of diabetes and bone diseases are two important and frequent complications of CF. Patients with CF being at risk of vitamin K deficiencies, this vitamin could play a role in these complications.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with CF
* Aged above 18 years
* Pancreatic insufficient
* Subjects with an OGTT test in the last 12 months or subjects who are diabetic
Exclusion Criteria:
* Receive or have received, in the last 6 months, a supplement of vitamin K (dose greater than 500 mcg per day)
* Subjects with a pulmonary function under 30%
* Subjects with severe gastrointestinal disease (Crohn disease, coeliac disease and recent (\<1 year) history of intestinal occlusion).
* Subjects with a history of liver disease (severe or transplant)
* Known allergy or intolerance to phylloquinone (oral form of vitamin K)
* Pregnancy (current or planned in the next 6 months)
* Subjects with signs of active secondary infections should wait at least 1 month after the end of antibiotic treatment in order to be included in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in serum vitamin K levels from baseline at 6 months
Timeframe: 0, 3 and 6 months
Trial details
NCT IDNCT04496921
SponsorInstitut de Recherches Cliniques de Montreal