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

Phase 4

Completed

• Conditions: Supplementation; Bone Health; Crohn's Disease
• Interventions: Dietary Supplement: placebo; Dietary Supplement: phylloquinone (vitamin K1)

• Registration Number: NCT01235325
• Lead Sponsor: University College Cork

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.

Study Timeline

• Study Start: 2008-07
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Last Update Submitted: 2010-11-05
• Last Update Posted: 2010-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo oil capsule	placebo	Banner Pharmacaps Europe
phylloquinone (1000 mcg)	phylloquinone (vitamin K1)	Banner Pharmacaps Europe

Primary Outcome Measures

Name	Time	Method
% Undercarboxylated osteocalcin	12 months	Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status.

Secondary Outcome Measures

Name	Time	Method
25-Hydroxy vitamin D (25OHD)	12 months	Measurement of serum 25-Hydroxy vitamin D as status measure
Intact Parathyroid hormone (iPTH)	12 months	Measurement of intact parathyroid hormone to determine hyperparathyroidism, hypercalcemia, vitamin D deficiency
Urinary creatinine	12 months	For standardisation of urinary NTx measurement
Serum phylloquinone	12 months	Determination of serum phylloquinone by HPLC
Biochemical markers of bone turnover (BAP, CTx, NTx)	12 months	Use of biochemical markers of bone turnover to assess the effect of supplementation on bone health.
Bone mineral density (BMD)	12 month	Measurement of bone mineral density (BMD) by iDEXA
Food Frequency Questionnaire (FFQ) for habitual vitamin K, vitamin D and calcium intakes	cross-sectional (baseline only)	Food frequency questionnaire (FFQ) to estimate habitual vitamin K (vitamin D and calcium) status, cross-sectionally at baseline.

Trial Locations

Locations (1)

Clinical Investigations Unit, Cork University Hospital, Wilton; 🇮🇪 Cork, Co. Cork, Ireland