Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

Study Overview
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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.

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

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Dietary Supplement: Vitamin K supplementation, dose #1
* Dietary Supplement: Vitamin K supplementation, dose #2


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin K supplement, dose #1<br>Vitamin K supplementation with dose #1 | Dietary Supplement: Vitamin K supplementation, dose #1<br>* 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.<br>|
| Active Comparator: Vitamin K supplement, dose #2<br>Vitamin K supplementation with dose #2 | Dietary Supplement: Vitamin K supplementation, dose #2<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin K, Supplementation, Nutrition, Diabetes