ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01235325
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : November 9, 2010
Sponsor:
Collaborator:
Health Research Board, Ireland
Information provided by:
University College Cork

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

Condition or disease Intervention/treatment Phase
Supplementation Bone Health Crohn's Disease Dietary Supplement: phylloquinone (vitamin K1) Dietary Supplement: placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease
Study Start Date : July 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. % Undercarboxylated osteocalcin [ Time Frame: 12 months ]
    Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status.


Secondary Outcome Measures :
  1. 25-Hydroxy vitamin D (25OHD) [ Time Frame: 12 months ]
    Measurement of serum 25-Hydroxy vitamin D as status measure

  2. Intact Parathyroid hormone (iPTH) [ Time Frame: 12 months ]
    Measurement of intact parathyroid hormone to determine hyperparathyroidism, hypercalcemia, vitamin D deficiency

  3. Urinary creatinine [ Time Frame: 12 months ]
    For standardisation of urinary NTx measurement

  4. Serum phylloquinone [ Time Frame: 12 months ]
    Determination of serum phylloquinone by HPLC

  5. Biochemical markers of bone turnover (BAP, CTx, NTx) [ Time Frame: 12 months ]
    Use of biochemical markers of bone turnover to assess the effect of supplementation on bone health.

  6. Bone mineral density (BMD) [ Time Frame: 12 month ]
    Measurement of bone mineral density (BMD) by iDEXA

  7. Food Frequency Questionnaire (FFQ) for habitual vitamin K, vitamin D and calcium intakes [ Time Frame: cross-sectional (baseline only) ]
    Food frequency questionnaire (FFQ) to estimate habitual vitamin K (vitamin D and calcium) status, cross-sectionally at baseline.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: November 2010

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
Vitamins
Vitamin K
Vitamin K 1
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants