SupplementationPhase 4NCT01235325
The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients
A Phase 4 study testing phylloquinone (vitamin K1) in people with Supplementation and Bone Health, run by University College Cork at 1 site in Ireland.
Trial summary
To assess the impact of a 12 month vitamin K supplementation intervention on bone health in adult Crohn's disease patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Supplementation, Bone Health, Crohn's Disease
- What is being tested?
- phylloquinone (vitamin K1)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIreland
- Study dates
- Jul 2008to Nov 2010
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- long-standing Crohn's disease - disease diagnosis > 5 years
- in clinical remission at baseline - Harvey-Bradshaw score (< 5)
- aged between 18-70 years
Who cannot join
- use of steroid medications to treat disease or flare up
- use of blood thinning medications (warfarin, heparin, asprin, dicoumarol derivatives) which may influence vitamin K metabolism
- use of bisphosphonates, calcitonin medications (to treat osteoporosis)
- use of experimental drugs (in the last 30 days) or inclusion in another intervention trial
- bone mineral density < -2.5 (indicative of osteoporosis) or previous diagnosis of osteoporosis
- use of vitamin/mineral/fish liver oil dietary supplements
Show all 10Show fewer
- use of other alternative supplements (i.e herbal)
- if the patient is under 18 or over 70 years of age
- presence of a significant acute or chronic coexisting illness (cardiovascular, immunological or a condition which in the investigator's judgement, contraindicates involvement in the study)
- presence of malignant or any concomitant end-stage organ disease
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Clinical Investigations Unit, Cork University Hospital, Wilton
Cork, Co. Cork, 00000
About this study
Official title: The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease
To assess the impact of a 12 month vitamin K supplementation intervention on bone health in adult Crohn's disease patients
Read the detailed description
To assess the impact of 12 months of vitamin K1 supplementation (plus vitamin D and calcium supplementation to avoid deficiency of these problematic nutrients) at a level which leads to dramatically (i.e greater than 70%) reduced levels of undercarboxylated osteocalcin - a functional marker of vitamin K status, on vitamin K status, the rate of bone formation and bone resorption, using biochemical markers of bone turnover, and bone mineral density in adult patients with longstanding Crohn's disease.
- Conditions
- Supplementation, Bone Health, Crohn's Disease
- Being tested
- phylloquinone (vitamin K1), placebo
- Keywords
- vitamin K, supplementation, bone health indices, adult, Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phylloquinone (vitamin K1)Dietary supplement
Also called Banner Pharmacaps Europe
1000 mcg phylloquinone (vitamin K1) once daily for 12 months
placeboDietary supplement
Also called Banner Pharmacaps Europe
placebo oil capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo oil capsule | Placebo comparator | Banner Pharmacaps Europe Receives: Dietary Supplement: placebo |
| phylloquinone (1000 mcg) | Experimental | Banner Pharmacaps Europe Receives: Dietary Supplement: phylloquinone (vitamin K1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Undercarboxylated osteocalcin
Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status.
Measured: 12 months
Secondary outcomes (7)
25-Hydroxy vitamin D (25OHD)
Measurement of serum 25-Hydroxy vitamin D as status measure
Measured: 12 months
Intact Parathyroid hormone (iPTH)
Measurement of intact parathyroid hormone to determine hyperparathyroidism, hypercalcemia, vitamin D deficiency
Measured: 12 months
Urinary creatinine
For standardisation of urinary NTx measurement
Measured: 12 months
Serum phylloquinone
Determination of serum phylloquinone by HPLC
Measured: 12 months
Biochemical markers of bone turnover (BAP, CTx, NTx)
Use of biochemical markers of bone turnover to assess the effect of supplementation on bone health.
Measured: 12 months
Bone mineral density (BMD)
Measurement of bone mineral density (BMD) by iDEXA
Measured: 12 month
Food Frequency Questionnaire (FFQ) for habitual vitamin K, vitamin D and calcium intakes
Food frequency questionnaire (FFQ) to estimate habitual vitamin K (vitamin D and calcium) status, cross-sectionally at baseline.
Measured: cross-sectional (baseline only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startJul 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SupplementationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Investigators
- Kevin D Cashman, Professor, Principal investigator, University College Cork, IrelandFergus Shanahan, Professor, Study director, University College Cork, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235325
- Sponsor's protocol ID
- HRB RP/2006/38
- Status last verified
- Nov 2010
- First submitted
- 4 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease
- ClinicalTrials.gov ID
- NCT01235325
- Acronym / sponsor ID
- HRB RP/2006/38
- Conditions
- Supplementation, Bone Health, Crohn's Disease
- Keywords
- vitamin K, supplementation, bone health indices, adult, Crohn's disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- Jul 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 5 Nov 2010 (estimated)
- 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.
To assess the impact of a 12 month vitamin K supplementation intervention on bone health in adult Crohn's disease patients
Detailed description
To assess the impact of 12 months of vitamin K1 supplementation (plus vitamin D and calcium supplementation to avoid deficiency of these problematic nutrients) at a level which leads to dramatically (i.e greater than 70%) reduced levels of undercarboxylated osteocalcin - a functional marker of vitamin K status, on vitamin K status, the rate of bone formation and bone resorption, using biochemical markers of bone turnover, and bone mineral density in adult patients with longstanding Crohn's disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo oil capsule | Placebo comparator | Dietary Supplement: placeboBanner Pharmacaps Europe |
| phylloquinone (1000 mcg) | Experimental | Dietary Supplement: phylloquinone (vitamin K1)Banner Pharmacaps Europe |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- long-standing Crohn's disease - disease diagnosis > 5 years
- in clinical remission at baseline - Harvey-Bradshaw score (< 5)
- aged between 18-70 years
Key exclusion criteria (10 listed)
- use of steroid medications to treat disease or flare up
- use of blood thinning medications (warfarin, heparin, asprin, dicoumarol derivatives) which may influence vitamin K metabolism
- use of bisphosphonates, calcitonin medications (to treat osteoporosis)
- use of experimental drugs (in the last 30 days) or inclusion in another intervention trial
- bone mineral density < -2.5 (indicative of osteoporosis) or previous diagnosis of osteoporosis
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 |
|---|---|---|
| phylloquinone (vitamin K1)Also: Banner Pharmacaps Europe1000 mcg phylloquinone (vitamin K1) once daily for 12 months | Dietary supplement | phylloquinone (1000 mcg) |
| placeboAlso: Banner Pharmacaps Europeplacebo oil capsule | Dietary supplement | Placebo oil capsule |
Primary outcome
% Undercarboxylated osteocalcin
Time frame: 12 months
Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status.
7 secondary outcomes
25-Hydroxy vitamin D (25OHD)
Time frame: 12 months
Intact Parathyroid hormone (iPTH)
Time frame: 12 months
Urinary creatinine
Time frame: 12 months
Serum phylloquinone
Time frame: 12 months
Biochemical markers of bone turnover (BAP, CTx, NTx)
Time frame: 12 months
Bone mineral density (BMD)
Time frame: 12 month
Food Frequency Questionnaire (FFQ) for habitual vitamin K, vitamin D and calcium intakes
Time frame: cross-sectional (baseline only)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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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.
Kevin D Cashman, Professor principal investigator
University College Cork, Ireland
Fergus Shanahan, Professor study director
University College Cork, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing phylloquinone (vitamin K1) in people with Supplementation and Bone Health, run by University College Cork at 1 site in Ireland.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
% Undercarboxylated osteocalcin (time frame: 12 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 9 Nov 2010.