The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients
Information source: University College Cork
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Supplementation; Bone Health; Crohn's Disease
Intervention: phylloquinone (vitamin K1) (Dietary Supplement); placebo (Dietary Supplement)
Phase: Phase 4
Status: Completed
Sponsored by: University College Cork Official(s) and/or principal investigator(s): Kevin D Cashman, Professor, Principal Investigator, Affiliation: University College Cork, Ireland Fergus Shanahan, Professor, Study Director, Affiliation: University College Cork, Ireland
Summary
To assess the impact of a 12 month vitamin K supplementation intervention on bone health in
adult Crohn's disease patients
Clinical Details
Official title: The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Primary outcome: % Undercarboxylated osteocalcin
Secondary outcome: 25-Hydroxy vitamin D (25OHD)Intact Parathyroid hormone (iPTH) Urinary creatinine Serum phylloquinone Biochemical markers of bone turnover (BAP, CTx, NTx) Bone mineral density (BMD) Food Frequency Questionnaire (FFQ) for habitual vitamin K, vitamin D and calcium intakes
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Clinical Investigations Unit, Cork University Hospital, Wilton, Cork, Co. Cork 00000, Ireland
Additional Information
Starting date: July 2008
Last updated: November 5, 2010
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