Clinical Trials Directory

Trials / Completed

CompletedNCT01235325

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
70 (actual)
Sponsor
University College Cork · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTphylloquinone (vitamin K1)1000 mcg phylloquinone (vitamin K1) once daily for 12 months
DIETARY_SUPPLEMENTplaceboplacebo oil capsule

Timeline

Start date
2008-07-01
Primary completion
2010-11-01
Completion
2010-11-01
First posted
2010-11-05
Last updated
2010-11-09

Locations

1 site across 1 country: Ireland

Source: ClinicalTrials.gov record NCT01235325. Inclusion in this directory is not an endorsement.