Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— VITK-FK  

Official title:

Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis : A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04496921
• Other study ID #: VITK-FK
• Status: Withdrawn
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: August 16, 2021

Study information

• Verified date: August 2021
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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: - Group A: a vitamin K supplement of 2mg, every day for 6 months - Group B: a vitamin K supplement of 7mg, twice a week for 6 months

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 16, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Dietary Supplement:
• Vitamin K supplementation, dose #1
Vitamin K supplement : 2mg, once a day, for 6 months. Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.). Food frequency questionnaire.
• Vitamin K supplementation, dose #2
Vitamin K supplement : 7mg, twice a week, for 6 months. Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.). Food frequency questionnaire.

Locations

Country	Name	City	State
Canada	CHUM	Montréal	Quebec
Canada	Montreal Clinical Research Institute (IRCM)	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal	Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum vitamin K levels from baseline at 6 months	Impact of supplementation on vitamin K serum levels	0, 3 and 6 months
Secondary	Change in osteocalcin levels from baseline at 6 months	Impact of supplementation on osteocalcin levels (Total and uncarboxylated)	0, 3 and 6 months
Secondary	Patient's perception and side effects of the supplement	Visual analogue scale questionnaire	6 months
Secondary	Bone marker levels	Impact of supplementation on bone marker C-Telopeptide	0, 3 and 6 months
Secondary	Glycemic marker levels	Impact of supplementation on HbA1c levels and fructosamine levels	0, 3 and 6 months