Cystic Fibrosis
Conditions
Keywords
Vitamin K, Supplementation, Nutrition, Diabetes
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
Interventions
DIETARY_SUPPLEMENTVitamin 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.
DIETARY_SUPPLEMENTVitamin 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.
Sponsors
Université de Montréal
Institut de Recherches Cliniques de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in osteocalcin levels from baseline at 6 months | 0, 3 and 6 months | Impact of supplementation on osteocalcin levels (Total and uncarboxylated) |
| 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 |
Countries
Canada
Outcome results
None listed