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

Study Overview
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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.

Official Title
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The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease

Conditions
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Supplementation, Bone Health, Crohn's Disease

Intervention / Treatment
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* Dietary Supplement: phylloquinone (vitamin K1)
* Dietary Supplement: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo oil capsule<br>Banner Pharmacaps Europe | Dietary Supplement: placebo<br>* placebo oil capsule<br>* Other names: Banner Pharmacaps Europe;|
| Experimental: phylloquinone (1000 mcg)<br>Banner Pharmacaps Europe | Dietary Supplement: phylloquinone (vitamin K1)<br>* 1000 mcg phylloquinone (vitamin K1) once daily for 12 months<br>* Other names: Banner Pharmacaps Europe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Undercarboxylated osteocalcin | Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25-Hydroxy vitamin D (25OHD) | Measurement of serum 25-Hydroxy vitamin D as status measure | 12 months | 
| Intact Parathyroid hormone (iPTH) | Measurement of intact parathyroid hormone to determine hyperparathyroidism, hypercalcemia, vitamin D deficiency | 12 months | 
| Urinary creatinine | For standardisation of urinary NTx measurement | 12 months | 
| Serum phylloquinone | Determination of serum phylloquinone by HPLC | 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. | 12 months | 
| Bone mineral density (BMD) | Measurement of bone mineral density (BMD) by iDEXA | 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. | cross-sectional (baseline only) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin K, supplementation, bone health indices, adult, Crohn's disease