Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-10

Study Completion Date

2021-08-16

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* 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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vitamin K supplement, dose #1

Vitamin K supplementation with dose #1

Group Type ACTIVE_COMPARATOR

Vitamin K supplementation, dose #1

Intervention Type DIETARY_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 supplement, dose #2

Vitamin K supplementation with dose #2

Group Type ACTIVE_COMPARATOR

Vitamin K supplementation, dose #2

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No