Cystic FibrosisVITK-FKNCT04496921
Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis
A study testing Vitamin K supplementation, dose #1 and Vitamin K supplementation, dose #2 in people with Cystic Fibrosis, run by Institut de Recherches Cliniques de Montreal at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Vitamin K supplementation, dose #1 and Vitamin K supplementation, dose #2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Aug 2020to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with CF
- Aged above 18 years
- Pancreatic insufficient
- Subjects with an OGTT test in the last 12 months or subjects who are diabetic
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal Clinical Research Institute (IRCM)
Montreal, Quebec, H2W1R7
CHUM
Montreal, Quebec
About this study
Official title: Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis : A Pilot Study
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.
Read the 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
- Being tested
- Vitamin K supplementation, dose #1, Vitamin K supplementation, dose #2
- Keywords
- Vitamin K, Supplementation, Nutrition, Diabetes
- Medical subject headings
- Cystic Fibrosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K supplementation, dose #1Dietary 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 supplementation, dose #2Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K supplement, dose #1 | Active comparator | Vitamin K supplementation with dose #1 Receives: Dietary Supplement: Vitamin K supplementation, dose #1 |
| Vitamin K supplement, dose #2 | Active comparator | Vitamin K supplementation with dose #2 Receives: Dietary Supplement: Vitamin K supplementation, dose #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum vitamin K levels from baseline at 6 months
Impact of supplementation on vitamin K serum levels
Measured: 0, 3 and 6 months
Secondary outcomes (4)
Change in osteocalcin levels from baseline at 6 months
Impact of supplementation on osteocalcin levels (Total and uncarboxylated)
Measured: 0, 3 and 6 months
Patient's perception and side effects of the supplement
Visual analogue scale questionnaire
Measured: 6 months
Bone marker levels
Impact of supplementation on bone marker C-Telopeptide
Measured: 0, 3 and 6 months
Glycemic marker levels
Impact of supplementation on HbA1c levels and fructosamine levels
Measured: 0, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start10 Aug 2020
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Why it stopped: Clinical care of patients with CF changed following COVID-19 pandemic (OGTT not performed at the CF clinic since March 2020); in consequence, this study is no longer feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Rémi Rabasa-Lhoret, MD, PhD, Principal investigator, Montreal Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496921
- Sponsor's protocol ID
- VITK-FK
- Acronym
- VITK-FK
- Status last verified
- Aug 2021
- First submitted
- 21 Jul 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis : A Pilot Study
- ClinicalTrials.gov ID
- NCT04496921
- Acronym / sponsor ID
- VITK-FK / VITK-FK
- Conditions
- Cystic Fibrosis
- Keywords
- Vitamin K, Supplementation, Nutrition, Diabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Clinical care of patients with CF changed following COVID-19 pandemic (OGTT not performed at the CF clinic since March 2020); in consequence, this study is no longer feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Vitamin K supplement, dose #1 | Active comparator | Dietary Supplement: Vitamin K supplementation, dose #1Vitamin K supplementation with dose #1 |
| Vitamin K supplement, dose #2 | Active comparator | Dietary Supplement: Vitamin K supplementation, dose #2Vitamin K supplementation with dose #2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with CF
- Aged above 18 years
- Pancreatic insufficient
- Subjects with an OGTT test in the last 12 months or subjects who are diabetic
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K supplementation, dose #1Vitamin 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 supplement, dose #1 |
| Vitamin K supplementation, dose #2Vitamin 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. | Dietary supplement | Vitamin K supplement, dose #2 |
Primary outcome
Change in serum vitamin K levels from baseline at 6 months
Time frame: 0, 3 and 6 months
Impact of supplementation on vitamin K serum levels
4 secondary outcomes
Change in osteocalcin levels from baseline at 6 months
Time frame: 0, 3 and 6 months
Patient's perception and side effects of the supplement
Time frame: 6 months
Bone marker levels
Time frame: 0, 3 and 6 months
Glycemic marker levels
Time frame: 0, 3 and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémi Rabasa-Lhoret, MD, PhD principal investigator
Montreal Clinical Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K supplementation, dose #1 and Vitamin K supplementation, dose #2 in people with Cystic Fibrosis, run by Institut de Recherches Cliniques de Montreal at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum vitamin K levels from baseline at 6 months (time frame: 0, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.