Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

NCT04496921 | Withdrawn

• 1 other identifier: VITK-FK
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis

Keywords

Vitamin K; Supplementation; Nutrition; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in osteocalcin levels from baseline at 6 months

  0, 3 and 6 months

• Patient's perception and side effects of the supplement

  6 months

• Bone marker levels

  0, 3 and 6 months

• Glycemic marker levels

  0, 3 and 6 months

Study Arms (2)

Vitamin K supplement, dose #1

ACTIVE COMPARATOR

Vitamin K supplementation with dose #1

Dietary Supplement: Vitamin K supplementation, dose #1

Vitamin K supplement, dose #2

ACTIVE COMPARATOR

Vitamin K supplementation with dose #2

Dietary Supplement: Vitamin K supplementation, dose #2

Interventions

Vitamin K supplementation, dose #1 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 #1

Vitamin K supplementation, dose #2 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.

Vitamin K supplement, dose #2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with CF
• Aged above 18 years
• Pancreatic insufficient
• Subjects with an OGTT test in the last 12 months or subjects who are diabetic

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead
• Université de Montréal: collaborator

Study Sites (2)

Montreal Clinical Research Institute (IRCM)

Montreal, Quebec, H2W1R7, Canada

Location

CHUM

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rémi Rabasa-Lhoret, MD, PhD

  Montreal Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: August 4, 2020
• Study Start: August 10, 2020
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)