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

Study Overview

• Status: Completed
• Conditions: Supplementation; Crohn's Disease; Bone Health
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: phylloquinone (vitamin K1)

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
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Ireland
  • Co. Cork
    • Cork, Co. Cork, Ireland, 00000
      • Clinical Investigations Unit, Cork University Hospital, Wilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo oil capsule; Banner Pharmacaps Europe	Dietary supplement: placebo; placebo oil capsule; Other Names: 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 Names: Banner Pharmacaps Europe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Undercarboxylated osteocalcin	Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
25-Hydroxy vitamin D (25OHD)	Measurement of serum 25-Hydroxy vitamin D as status measure	12 months
Intact Parathyroid hormone (iPTH)	Measurement of intact parathyroid hormone to determine hyperparathyroidism, hypercalcemia, vitamin D deficiency	12 months
Urinary creatinine	For standardisation of urinary NTx measurement	12 months
Serum phylloquinone	Determination of serum phylloquinone by HPLC	12 months
Biochemical markers of bone turnover (BAP, CTx, NTx)	Use of biochemical markers of bone turnover to assess the effect of supplementation on bone health.	12 months
Bone mineral density (BMD)	Measurement of bone mineral density (BMD) by iDEXA	12 month
Food Frequency Questionnaire (FFQ) for habitual vitamin K, vitamin D and calcium intakes	Food frequency questionnaire (FFQ) to estimate habitual vitamin K (vitamin D and calcium) status, cross-sectionally at baseline.	cross-sectional (baseline only)

Collaborators and Investigators

• Sponsor: University College Cork
• Collaborators: Health Research Board, Ireland
• Investigators: Principal Investigator: Kevin D Cashman, Professor, University College Cork, Ireland; Study Director: Fergus Shanahan, Professor, University College Cork, Ireland

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): November 1, 2010

Study Registration Dates

• First Submitted: November 4, 2010
• First Submitted That Met QC Criteria: November 4, 2010
• First Posted (ESTIMATE): November 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 9, 2010
• Last Update Submitted That Met QC Criteria: November 5, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: adult; supplementation; Crohn's disease; vitamin K; bone health indices
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Micronutrients; Vitamins; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Vitamin K 1
• Other Study ID Numbers: HRB RP/2006/38