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

Primary Purpose

Cystic Fibrosis

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vitamin K supplementation, dose #1
Vitamin K supplementation, dose #2
Sponsored by
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cystic Fibrosis focused on measuring Vitamin K, Supplementation, Nutrition, Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Montreal Clinical Research Institute (IRCM)
  • CHUM

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vitamin K supplement, dose #1

Vitamin K supplement, dose #2

Arm Description

Vitamin K supplementation with dose #1

Vitamin K supplementation with dose #2

Outcomes

Primary Outcome Measures

Change in serum vitamin K levels from baseline at 6 months
Impact of supplementation on vitamin K serum levels

Secondary Outcome Measures

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

Full Information

First Posted
July 21, 2020
Last Updated
August 16, 2021
Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT04496921
Brief Title
Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis
Acronym
VITK-FK
Official Title
Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis : A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why 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.
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
August 16, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
Université de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Vitamin K, Supplementation, Nutrition, Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 months
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin K supplement, dose #1
Arm Type
Active Comparator
Arm Description
Vitamin K supplementation with dose #1
Arm Title
Vitamin K supplement, dose #2
Arm Type
Active Comparator
Arm Description
Vitamin K supplementation with dose #2
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K supplementation, dose #1
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K supplementation, dose #2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in serum vitamin K levels from baseline at 6 months
Description
Impact of supplementation on vitamin K serum levels
Time Frame
0, 3 and 6 months
Secondary Outcome Measure Information:
Title
Change in osteocalcin levels from baseline at 6 months
Description
Impact of supplementation on osteocalcin levels (Total and uncarboxylated)
Time Frame
0, 3 and 6 months
Title
Patient's perception and side effects of the supplement
Description
Visual analogue scale questionnaire
Time Frame
6 months
Title
Bone marker levels
Description
Impact of supplementation on bone marker C-Telopeptide
Time Frame
0, 3 and 6 months
Title
Glycemic marker levels
Description
Impact of supplementation on HbA1c levels and fructosamine levels
Time Frame
0, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémi Rabasa-Lhoret, MD, PhD
Organizational Affiliation
Montreal Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Clinical Research Institute (IRCM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W1R7
Country
Canada
Facility Name
CHUM
City
Montréal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

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