Bone Health, Crohn's Disease, Supplementation
Conditions
Keywords
vitamin K, supplementation, bone health indices, adult, Crohn's disease
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.
Interventions
DIETARY_SUPPLEMENTphylloquinone (vitamin K1)
1000 mcg phylloquinone (vitamin K1) once daily for 12 months
DIETARY_SUPPLEMENTplacebo
placebo oil capsule
Sponsors
Health Research Board, Ireland
University College Cork
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Undercarboxylated osteocalcin | 12 months | Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density (BMD) | 12 month | Measurement of bone mineral density (BMD) by iDEXA |
| 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 |
| 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. |
| Serum phylloquinone | 12 months | Determination of serum phylloquinone by HPLC |
| 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. |
| Urinary creatinine | 12 months | For standardisation of urinary NTx measurement |
Countries
Ireland
Outcome results
None listed