Status:
COMPLETED
The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients
Lead Sponsor:
University College Cork
Collaborating Sponsors:
Health Research Board, Ireland
Conditions:
Supplementation
Bone Health
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 (...
Eligibility Criteria
Inclusion
- long-standing Crohn's disease - disease diagnosis \> 5 years
- in clinical remission at baseline - Harvey-Bradshaw score (\< 5)
- aged between 18-70 years
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01235325
Start Date
July 1 2008
End Date
November 1 2010
Last Update
November 9 2010
Active Locations (1)
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1
Clinical Investigations Unit, Cork University Hospital, Wilton
Cork, Co. Cork, Ireland, 00000