Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

Institut de Recherches Cliniques de Montreal

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Cystic Fibrosis

Interventions

Vitamin K supplementation, dose #1DIETARY_SUPPLEMENT

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 #2DIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Montreal Clinical Research Institute (IRCM)

Montreal, Quebec, Canada

CHUM

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Change in serum vitamin K levels from baseline at 6 months

Impact of supplementation on vitamin K serum levels

Time frame: 0, 3 and 6 months

Secondary Outcomes

Change in osteocalcin levels from baseline at 6 months

Impact of supplementation on osteocalcin levels (Total and uncarboxylated)

Time frame: 0, 3 and 6 months

Patient's perception and side effects of the supplement

Visual analogue scale questionnaire

Time frame: 6 months

Bone marker levels

Impact of supplementation on bone marker C-Telopeptide

Time frame: 0, 3 and 6 months

Glycemic marker levels

Impact of supplementation on HbA1c levels and fructosamine levels

Time frame: 0, 3 and 6 months

Data from ClinicalTrials.gov

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