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| Name | Class |
|---|---|
| Health Research Board, Ireland | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo oil capsule | Placebo Comparator | Banner Pharmacaps Europe |
|
| phylloquinone (1000 mcg) | Experimental | Banner Pharmacaps Europe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phylloquinone (vitamin K1) | Dietary Supplement | 1000 mcg phylloquinone (vitamin K1) once daily for 12 months |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin D Cashman, Professor | University College Cork, Ireland | Principal Investigator |
| Fergus Shanahan, Professor | University College Cork, Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigations Unit, Cork University Hospital, Wilton | Cork | Co. Cork | 00000 | Ireland |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010837 | Vitamin K 1 |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| placebo | Dietary Supplement | placebo oil capsule |
|
|
| 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) |
| D007410 | Intestinal Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |