DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: University College Cork
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Supplementation; Bone Health; Crohn's Disease

Intervention: phylloquinone (vitamin K1) (Dietary Supplement); placebo (Dietary Supplement)

Phase: Phase 4

Status: Completed

Sponsored by: University College Cork

Official(s) and/or principal investigator(s):
Kevin D Cashman, Professor, Principal Investigator, Affiliation: University College Cork, Ireland
Fergus Shanahan, Professor, Study Director, Affiliation: University College Cork, Ireland

Summary

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

Clinical Details

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

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

Primary outcome: % Undercarboxylated osteocalcin

Secondary outcome:

25-Hydroxy vitamin D (25OHD)

Intact Parathyroid hormone (iPTH)

Urinary creatinine

Serum phylloquinone

Biochemical markers of bone turnover (BAP, CTx, NTx)

Bone mineral density (BMD)

Food Frequency Questionnaire (FFQ) for habitual vitamin K, vitamin D and calcium intakes

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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 and Contacts

Clinical Investigations Unit, Cork University Hospital, Wilton, Cork, Co. Cork 00000, Ireland
Additional Information

Starting date: July 2008
Last updated: November 5, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017