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The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients

NCT ID: NCT01235325

Last Updated: 2010-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-11-30

Brief Summary

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To assess the impact of a 12 month vitamin K supplementation intervention on bone health in adult Crohn's disease patients

Detailed Description

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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

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Supplementation Bone Health Crohn's Disease

Keywords

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vitamin K supplementation bone health indices adult Crohn's disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo oil capsule

Banner Pharmacaps Europe

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

placebo oil capsule

phylloquinone (1000 mcg)

Banner Pharmacaps Europe

Group Type EXPERIMENTAL

phylloquinone (vitamin K1)

Intervention Type DIETARY_SUPPLEMENT

1000 mcg phylloquinone (vitamin K1) once daily for 12 months

Interventions

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phylloquinone (vitamin K1)

1000 mcg phylloquinone (vitamin K1) once daily for 12 months

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo oil capsule

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Banner Pharmacaps Europe Banner Pharmacaps Europe

Eligibility Criteria

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Inclusion Criteria

* long-standing Crohn's disease - disease diagnosis \> 5 years
* in clinical remission at baseline - Harvey-Bradshaw score (\< 5)
* aged between 18-70 years

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Research Board, Ireland

OTHER

Sponsor Role collaborator

University College Cork

OTHER

Sponsor Role lead

Responsible Party

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University College Cork, Ireland

Principal Investigators

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Kevin D Cashman, Professor

Role: PRINCIPAL_INVESTIGATOR

University College Cork, Ireland

Fergus Shanahan, Professor

Role: STUDY_DIRECTOR

University College Cork, Ireland

Locations

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Clinical Investigations Unit, Cork University Hospital, Wilton

Cork, Co. Cork, Ireland

Site Status

Countries

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Ireland

Other Identifiers

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HRB RP/2006/38

Identifier Type: -

Identifier Source: org_study_id