The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- % Undercarboxylated osteocalcin
研究概览
简要总结
To assess the impact of a 12 month vitamin K supplementation intervention on bone health in adult Crohn's disease patients
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •long-standing Crohn's disease - disease diagnosis > 5 years
- •in clinical remission at baseline - Harvey-Bradshaw score (< 5)
- •aged between 18-70 years
排除标准
- •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
结局指标
主要结局
% Undercarboxylated osteocalcin
时间窗: 12 months
Measurement of carboxylated and undercarboxylated osteocalcin (expressed as %) as a senstive functional marker of vitamin K status.
次要结局
- 25-Hydroxy vitamin D (25OHD)(12 months)
- Intact Parathyroid hormone (iPTH)(12 months)
- Urinary creatinine(12 months)
- Serum phylloquinone(12 months)
- Biochemical markers of bone turnover (BAP, CTx, NTx)(12 months)
- Bone mineral density (BMD)(12 month)
- Food Frequency Questionnaire (FFQ) for habitual vitamin K, vitamin D and calcium intakes(cross-sectional (baseline only))