NCT04496921

Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institut de Recherches Cliniques de Montreal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
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.

Timeline

• Start date: 2020-08-10
• Primary completion: 2021-08-16
• Completion: 2021-08-16
• First posted: 2020-08-04
• Last updated: 2021-08-20

Locations

2 sites across 1 country: Canada