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

This study has been completed.
Health Research Board, Ireland
Information provided by:
University College Cork Identifier:
First received: November 4, 2010
Last updated: November 5, 2010
Last verified: November 2010

To assess the impact of a 12 month vitamin K supplementation intervention on bone health in adult Crohn's disease patients

Condition Intervention Phase
Bone Health
Crohn's Disease
Dietary Supplement: phylloquinone (vitamin K1)
Dietary Supplement: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease

Resource links provided by NLM:

Further study details as provided by University College Cork:

Primary Outcome Measures:
  • % Undercarboxylated osteocalcin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status.

Secondary Outcome Measures:
  • 25-Hydroxy vitamin D (25OHD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurement of serum 25-Hydroxy vitamin D as status measure

  • Intact Parathyroid hormone (iPTH) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurement of intact parathyroid hormone to determine hyperparathyroidism, hypercalcemia, vitamin D deficiency

  • Urinary creatinine [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    For standardisation of urinary NTx measurement

  • Serum phylloquinone [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determination of serum phylloquinone by HPLC

  • Biochemical markers of bone turnover (BAP, CTx, NTx) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Use of biochemical markers of bone turnover to assess the effect of supplementation on bone health.

  • Bone mineral density (BMD) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Measurement of bone mineral density (BMD) by iDEXA

  • Food Frequency Questionnaire (FFQ) for habitual vitamin K, vitamin D and calcium intakes [ Time Frame: cross-sectional (baseline only) ] [ Designated as safety issue: No ]
    Food frequency questionnaire (FFQ) to estimate habitual vitamin K (vitamin D and calcium) status, cross-sectionally at baseline.

Enrollment: 70
Study Start Date: July 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo oil capsule
Banner Pharmacaps Europe
Dietary Supplement: placebo
placebo oil capsule
Other Name: Banner Pharmacaps Europe
Experimental: phylloquinone (1000 mcg)
Banner Pharmacaps Europe
Dietary Supplement: phylloquinone (vitamin K1)
1000 mcg phylloquinone (vitamin K1) once daily for 12 months
Other Name: Banner Pharmacaps Europe

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01235325

Clinical Investigations Unit, Cork University Hospital, Wilton
Cork, Co. Cork, Ireland, 00000
Sponsors and Collaborators
University College Cork
Health Research Board, Ireland
Principal Investigator: Kevin D Cashman, Professor University College Cork, Ireland
Study Director: Fergus Shanahan, Professor University College Cork, Ireland
  More Information

No publications provided

Responsible Party: Professor Kevin D. Cashman, University College Cork, Ireland Identifier: NCT01235325     History of Changes
Other Study ID Numbers: HRB RP/2006/38
Study First Received: November 4, 2010
Last Updated: November 5, 2010
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Cork:
vitamin K
bone health indices
Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vitamin K 1
Vitamin K
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Therapeutic Uses processed this record on April 20, 2014