Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Health Research Board, Ireland
Information provided by:
University College Cork
ClinicalTrials.gov Identifier:
NCT01235325
First received: November 4, 2010
Last updated: November 5, 2010
Last verified: November 2010

November 4, 2010
November 5, 2010
July 2008
November 2010   (final data collection date for primary outcome measure)
% 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.
Same as current
Complete list of historical versions of study NCT01235325 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients
The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
  • Supplementation
  • Bone Health
  • Crohn's Disease
  • Dietary Supplement: phylloquinone (vitamin K1)
    1000 mcg phylloquinone (vitamin K1) once daily for 12 months
    Other Name: Banner Pharmacaps Europe
  • Dietary Supplement: placebo
    placebo oil capsule
    Other Name: Banner Pharmacaps Europe
  • Placebo Comparator: Placebo oil capsule
    Banner Pharmacaps Europe
    Intervention: Dietary Supplement: placebo
  • Experimental: phylloquinone (1000 mcg)
    Banner Pharmacaps Europe
    Intervention: Dietary Supplement: phylloquinone (vitamin K1)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT01235325
HRB RP/2006/38
Yes
Professor Kevin D. Cashman, University College Cork, Ireland
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
University College Cork
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP