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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | phylloquinone (vitamin K1) | 1000 mcg phylloquinone (vitamin K1) once daily for 12 months |
| DIETARY_SUPPLEMENT | placebo | placebo 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.