To assess the impact of a 12 month vitamin K supplementation intervention on bone health in adult Crohn's disease patients
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
70
1000 mcg phylloquinone (vitamin K1) once daily for 12 months
placebo oil capsule
Clinical Investigations Unit, Cork University Hospital, Wilton
Cork, Co. Cork, Ireland
% Undercarboxylated osteocalcin
Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status.
Time frame: 12 months
25-Hydroxy vitamin D (25OHD)
Measurement of serum 25-Hydroxy vitamin D as status measure
Time frame: 12 months
Intact Parathyroid hormone (iPTH)
Measurement of intact parathyroid hormone to determine hyperparathyroidism, hypercalcemia, vitamin D deficiency
Time frame: 12 months
Urinary creatinine
For standardisation of urinary NTx measurement
Time frame: 12 months
Serum phylloquinone
Determination of serum phylloquinone by HPLC
Time frame: 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.
Time frame: 12 months
Bone mineral density (BMD)
Measurement of bone mineral density (BMD) by iDEXA
Time frame: 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.
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Time frame: cross-sectional (baseline only)