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

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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

NCT01235325•University College Cork

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

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

Locations (1)

Clinical Investigations Unit, Cork University Hospital, Wilton

Cork, Co. Cork, Ireland

Key Dates

Start Date

July 1, 2008

Primary Completion Date

November 1, 2010

Completion Date

November 1, 2010

Last Updated

November 9, 2010

Enrollment

ACTUAL participants

Conditions

SupplementationBone HealthCrohn's Disease

Interventions

phylloquinone (vitamin K1)

DIETARY_SUPPLEMENT

placebo

DIETARY_SUPPLEMENT

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Protein Supplementation Intervention on Body Weight

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