Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

Not Applicable

Withdrawn

• Conditions: Cystic Fibrosis
• Interventions: Dietary Supplement: Vitamin K supplementation, dose #2; Dietary Supplement: Vitamin K supplementation, dose #1

• Registration Number: NCT04496921
• Lead Sponsor: Institut de Recherches Cliniques de Montreal

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

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-04
• Study Start: 2020-08-10
• Status Verified: 2021-08
• Primary Completion: 2021-08-16
• Study Completion: 2021-08-16
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin K supplement, dose #2	Vitamin K supplementation, dose #2	Vitamin K supplementation with dose #2
Vitamin K supplement, dose #1	Vitamin K supplementation, dose #1	Vitamin K supplementation with dose #1

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Change in osteocalcin levels from baseline at 6 months	0, 3 and 6 months	Impact of supplementation on osteocalcin levels (Total and uncarboxylated)

Trial Locations

Locations (2)

Montreal Clinical Research Institute (IRCM); 🇨🇦 Montréal, Quebec, Canada

CHUM; 🇨🇦 Montréal, Quebec, Canada