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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235325
• Other study ID #: HRB RP/2006/38
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2010
• Last updated: November 5, 2010
• Start date: July 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Health
• Crohn Disease
• Crohn's Disease
• Supplementation

Intervention

Dietary Supplement:
• phylloquinone (vitamin K1)
1000 mcg phylloquinone (vitamin K1) once daily for 12 months
• placebo
placebo oil capsule

Locations

Country	Name	City	State
Ireland	Clinical Investigations Unit, Cork University Hospital, Wilton	Cork	Co. Cork

Sponsors (2)

Lead Sponsor	Collaborator
University College Cork	Health Research Board, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Undercarboxylated osteocalcin	Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status.	12 months	No
Secondary	25-Hydroxy vitamin D (25OHD)	Measurement of serum 25-Hydroxy vitamin D as status measure	12 months	No
Secondary	Intact Parathyroid hormone (iPTH)	Measurement of intact parathyroid hormone to determine hyperparathyroidism, hypercalcemia, vitamin D deficiency	12 months	No
Secondary	Urinary creatinine	For standardisation of urinary NTx measurement	12 months	No
Secondary	Serum phylloquinone	Determination of serum phylloquinone by HPLC	12 months	No
Secondary	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	No
Secondary	Bone mineral density (BMD)	Measurement of bone mineral density (BMD) by iDEXA	12 month	No
Secondary	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)	No