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

Primary Purpose

Supplementation, Bone Health, Crohn's Disease

Status

Completed

Phase

Phase 4

Locations

Ireland

Study Type

Interventional

Intervention

phylloquinone (vitamin K1)

placebo

About this trial

This is an interventional prevention trial for Supplementation focused on measuring vitamin K, supplementation, bone health indices, adult, Crohn's disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinical Investigations Unit, Cork University Hospital, Wilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo oil capsule

phylloquinone (1000 mcg)

Arm Description

Banner Pharmacaps Europe

Outcomes

Primary Outcome Measures

% Undercarboxylated osteocalcin

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)

Measurement of serum 25-Hydroxy vitamin D as status measure

Intact Parathyroid hormone (iPTH)

Measurement of intact parathyroid hormone to determine hyperparathyroidism, hypercalcemia, vitamin D deficiency

Urinary creatinine

For standardisation of urinary NTx measurement

Serum phylloquinone

Determination of serum phylloquinone by HPLC

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

Use of biochemical markers of bone turnover to assess the effect of supplementation on bone health.

Bone mineral density (BMD)

Measurement of bone mineral density (BMD) by iDEXA

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.

Full Information

NCT ID

NCT01235325

First Posted

November 4, 2010

Last Updated

November 5, 2010

Sponsor

University College Cork

Collaborators

Health Research Board, Ireland

1. Study Identification

Unique Protocol Identification Number

NCT01235325

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University College Cork

Collaborators

Health Research Board, Ireland

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Supplementation, Bone Health, Crohn's Disease

Keywords

vitamin K, supplementation, bone health indices, adult, Crohn's disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo oil capsule

Arm Type

Placebo Comparator

Arm Description

Banner Pharmacaps Europe

Arm Title

phylloquinone (1000 mcg)

Arm Type

Experimental

Arm Description

Banner Pharmacaps Europe

Intervention Type

Dietary Supplement

Intervention Name(s)

phylloquinone (vitamin K1)

Other Intervention Name(s)

Banner Pharmacaps Europe

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Other Intervention Name(s)

Banner Pharmacaps Europe

Intervention Description

placebo oil capsule

Primary Outcome Measure Information:

Title

% Undercarboxylated osteocalcin

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

25-Hydroxy vitamin D (25OHD)

Description

Measurement of serum 25-Hydroxy vitamin D as status measure

Time Frame

12 months

Title

Intact Parathyroid hormone (iPTH)

Description

Measurement of intact parathyroid hormone to determine hyperparathyroidism, hypercalcemia, vitamin D deficiency

Time Frame

12 months

Title

Urinary creatinine

Description

For standardisation of urinary NTx measurement

Time Frame

12 months

Title

Serum phylloquinone

Description

Determination of serum phylloquinone by HPLC

Time Frame

12 months

Title

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

Description

Use of biochemical markers of bone turnover to assess the effect of supplementation on bone health.

Time Frame

12 months

Title

Bone mineral density (BMD)

Description

Measurement of bone mineral density (BMD) by iDEXA

Time Frame

12 month

Title

Food Frequency Questionnaire (FFQ) for habitual vitamin K, vitamin D and calcium intakes

Description

Food frequency questionnaire (FFQ) to estimate habitual vitamin K (vitamin D and calcium) status, cross-sectionally at baseline.

Time Frame

cross-sectional (baseline only)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin D Cashman, Professor

Organizational Affiliation

University College Cork, Ireland

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fergus Shanahan, Professor

Organizational Affiliation

University College Cork, Ireland

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Investigations Unit, Cork University Hospital, Wilton

City

Cork

State/Province

Co. Cork

ZIP/Postal Code

00000

Country

Ireland

12. IPD Sharing Statement

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

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