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Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

NCT04496921 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-08-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Université de Montréal

    collaborator OTHER

  • Institut de Recherches Cliniques de Montreal

    lead OTHER

Principal Investigators

  • Rémi Rabasa-Lhoret, MD, PhD · Montreal Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2021-08-16
Completion
2021-08-16

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04496921 on ClinicalTrials.gov