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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Dietary supplement: Vitamin K supplementation, dose #1; Dietary supplement: Vitamin K supplementation, dose #2

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • CHUM
    • Montréal, Quebec, Canada, H2W1R7
      • Montreal Clinical Research Institute (IRCM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut de Recherches Cliniques de Montreal
• Collaborators: Université de Montréal
• Investigators: Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD, Montreal Clinical Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2020
• Primary Completion (ACTUAL): August 16, 2021
• Study Completion (ACTUAL): August 16, 2021

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (ACTUAL): August 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes; Supplementation; Nutrition; Vitamin K
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Micronutrients; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Vitamins
• Other Study ID Numbers: VITK-FK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No