VITK-FK: Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

Sponsor

Institut de Recherches Cliniques de Montreal (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04496921

Collaborator

Université de Montréal (Other)

Enrollment

Locations

Arms

12.2

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Dietary Supplement: Vitamin K supplementation, dose #1 Dietary Supplement: Vitamin K supplementation, dose #2	N/A

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:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 10, 2020

Actual Primary Completion Date :

Aug 16, 2021

Actual Study Completion Date :

Aug 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vitamin K supplement, dose #1 Vitamin K supplementation with dose #1	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.
Active Comparator: Vitamin K supplement, dose #2 Vitamin K supplementation with dose #2	Dietary Supplement: 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.

Arm

Intervention/Treatment

Active Comparator: Vitamin K supplement, dose #1

Vitamin K supplementation with dose #1

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.

Active Comparator: Vitamin K supplement, dose #2

Vitamin K supplementation with dose #2

Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

Change in serum vitamin K levels from baseline at 6 months [0, 3 and 6 months]
Impact of supplementation on vitamin K serum levels

Secondary Outcome Measures

Change in osteocalcin levels from baseline at 6 months [0, 3 and 6 months]
Impact of supplementation on osteocalcin levels (Total and uncarboxylated)
Patient's perception and side effects of the supplement [6 months]
Visual analogue scale questionnaire
Bone marker levels [0, 3 and 6 months]
Impact of supplementation on bone marker C-Telopeptide
Glycemic marker levels [0, 3 and 6 months]
Impact of supplementation on HbA1c levels and fructosamine levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.