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
  Purpose

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


Condition Intervention Phase
Supplementation
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235325

Locations
Ireland
Clinical Investigations Unit, Cork University Hospital, Wilton
Cork, Co. Cork, Ireland, 00000
Sponsors and Collaborators
University College Cork
Health Research Board, Ireland
Investigators
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
ClinicalTrials.gov 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
supplementation
bone health indices
adult
Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vitamin K 1
Vitamin K
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014