Status:
WITHDRAWN
Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Collaborating Sponsors:
Université de Montréal
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
The investigators propose a pilot study (carried out to assess its feasibility on a larger scale) to evaluate if a supplement of vitamin K improves vitamin K serum levels in CF patients by comparing: ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04496921
Start Date
August 10 2020
End Date
August 16 2021
Last Update
August 20 2021
Active Locations (2)
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1
Montreal Clinical Research Institute (IRCM)
Montreal, Quebec, Canada, H2W1R7
2
CHUM
Montreal, Quebec, Canada