NCT01235325

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
Last Updated

November 9, 2010

Status Verified

November 1, 2010

Enrollment Period

2.3 years

First QC Date

November 4, 2010

Last Update Submit

November 5, 2010

Conditions

SupplementationBone HealthCrohn's Disease

Keywords

vitamin Ksupplementationbone health indicesadultCrohn's disease

Outcome Measures

Primary Outcomes (1)

  • % Undercarboxylated osteocalcin

    Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status.

    12 months

Secondary Outcomes (7)

  • 25-Hydroxy vitamin D (25OHD)

    12 months

  • Intact Parathyroid hormone (iPTH)

    12 months

  • Urinary creatinine

    12 months

  • Serum phylloquinone

    12 months

  • Biochemical markers of bone turnover (BAP, CTx, NTx)

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Placebo oil capsule

PLACEBO COMPARATOR

Banner Pharmacaps Europe

Dietary Supplement: placebo

phylloquinone (1000 mcg)

EXPERIMENTAL

Banner Pharmacaps Europe

Dietary Supplement: phylloquinone (vitamin K1)

Interventions

phylloquinone (vitamin K1)DIETARY_SUPPLEMENT

1000 mcg phylloquinone (vitamin K1) once daily for 12 months

Also known as: Banner Pharmacaps Europe
phylloquinone (1000 mcg)
placeboDIETARY_SUPPLEMENT

placebo oil capsule

Also known as: Banner Pharmacaps Europe
Placebo oil capsule

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • long-standing Crohn's disease - disease diagnosis \> 5 years
  • in clinical remission at baseline - Harvey-Bradshaw score (\< 5)
  • aged between 18-70 years

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Investigations Unit, Cork University Hospital, Wilton

Cork, Co. Cork, 00000, Ireland

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Vitamin K 1

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Vitamin KNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesQuinonesPolycyclic Compounds

Study Officials

  • Kevin D Cashman, Professor

    University College Cork, Ireland

    PRINCIPAL INVESTIGATOR

  • Fergus Shanahan, Professor

    University College Cork, Ireland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 5, 2010

Study Start

July 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 9, 2010

Record last verified: 2010-11

Locations

IE(1)