Clinical trial NCT01235325: The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients
Official title: The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Supplementation
Bone Health
Crohn's Disease
Keywords: vitamin K
supplementation
bone health indices
adult
Crohn's disease
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
First posted: 2010-11-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (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 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

Primary outcomes:
measure: % Undercarboxylated osteocalcin
timeFrame: 12 months
Secondary outcomes:
measure: 25-Hydroxy vitamin D (25OHD)
timeFrame: 12 months
measure: Intact Parathyroid hormone (iPTH)
timeFrame: 12 months
measure: Urinary creatinine
timeFrame: 12 months
measure: Serum phylloquinone
timeFrame: 12 months
measure: Biochemical markers of bone turnover (BAP, CTx, NTx)
timeFrame: 12 months
measure: Bone mineral density (BMD)
timeFrame: 12 month
measure: Food Frequency Questionnaire (FFQ) for habitual vitamin K, vitamin D and calcium intakes
timeFrame: cross-sectional (baseline only)
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Clinical Investigations Unit, Cork University Hospital, Wilton
state: Co. Cork
Study officials:
affiliation: University College Cork, Ireland
name: Kevin D Cashman, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Cork, Ireland
name: Fergus Shanahan, Professor
role: STUDY_DIRECTOR
References: