Nutritional Therapy for Patients With Acute Severe Ulcerative Colitis (ASUC) Treated With High-dose Steroids - a Special Focus on Protein and Magnesium.
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- 24 hour urine carbamide (mmol/d)
研究概览
简要总结
The aim of the study is to improve the quality of nutritional therapy for patients admitted with Acute Severe Ulcerative Colitis (ASUC) treated with high-dose steroids. This study consists of two randomized interventions and one observational part regarding protein, magnesium, and metabolic stress. First an interventional part aims to explore the effect of a high-protein diet during and after admission on different parameters regarding protein turnover.Second the study aims to explore the degree of magnesium depletion in ASUC. In case of magnesium depletion, the study aims to investigate whether oral magnesium supplementation can regain body stores of magnesium. Last the study aims to observe the degree of metabolic stress, including, the degree of insulin resistance, in ASUC during admission and under treatment with high-dose steroids compared to three weeks after discharge.
详细描述
Patients with Acute Severe Ulcerative Colitis (ASUC) may have an altered protein turnover due to inflammation, reduced dietary intake and/or accelerated protein loss. Despite this the level of dietary protein needed to maintain nitrogen balance has never been described in patients with ASUC. Clinical symptoms of ASUC include frequent and bloody diarrhea which alone or simultaneous with a risk of reduced dietary intake and weightloss can lead to magnesium depletion. Magnesium depletion can cause severe symptoms including cardiac arrhythmia and neuromuscular dysfunction which might worsen the disease further. The prevalence of magnesium depletion in ASUC has never been described and furthermore it is not known whether oral supplementation are able to reverse the condition in patients with ASUC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Cognizant
- •Must speak or read Danish or participate in relevant communication in interpreting or translating the study material.
- •Diagnosed with Acute Severe Ulcerative Colitis (ASUC) (documented in the patient journal)
- •Admitted at "Lever-, Mave-, og Tarmsygdomme/ LMT" at Aarhus University Hospital and in medical treatment with high-dose intravenous steroid (Solumedrol 40 mg x 2 daily)
排除标准
- •Pregnant and/or lactating women
- •Plasma creatinine > 200 µmol/L (protein intervention only)
- •Patients receiving tube- or parenteral feeding (protein intervention only)
- •Receiving any kind of magnesium supplementation 6 months prior to inclusion (magnesium intervention only)
- •Diagnosed with Type 1 or Type 2 Diabetes Mellitus (observational part only)
结局指标
主要结局
24 hour urine carbamide (mmol/d)
时间窗: 5 days
Change in 24 hour urine carbamide (mmol/d) from baseline (day 0) to first follow-up (day 5)
次要结局
- plasma carbamide (mmol/l)(0, follow-up 1 (day 5) and week 4)
- 24 hour urine carbamide (mmol/d)(4 weeks)
- 24 hour urine magnesium (mmol/d)(3 weeks)
- Fat free mass (FFM) (kg)(4 weeks)
- Fasting blood glucose (mmol/l)(4 weeks)
- Quality of life (QOL) questionaire (Hjortswang index)(3 weeks)
- plasma insulin (pmol/l)(4 weeks)
- Magnesium retention %(3 weeks)
- Resting Energy Expenditure (REE)(4 weeks)
- plasma magnesium (mmol/l)(4 weeks)
- plasma c-peptide (pmol/l)(4 weeks)
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)-score(4 weeks)
- 24 hour urine creatinine (mmol/d)(0, follow up 1 (day 5) and week 4)
- Quality of life (QOL) questionaire (SIBDQ)(3 weeks)
- Body weight (kg)(4 weeks)
- plasma albumin (g/L)(4 weeks)
- Creatinine-clearance (mL/min)(0, follow-up 1 (day 5) and week 4)
研究者
Christian Hvas
Associate professor, MD PhD
University of Aarhus