Protein and Magnesium in Ulcerative Colitis
- Conditions
- Nutritional DeficiencyColitis, UlcerativeMagnesium DeficiencyProtein DeficiencyInflammatory Bowel Diseases
- Interventions
- Dietary Supplement: Magnesium acetate mixture (30 mmol/ml)Dietary Supplement: High-protein diet (2 g/kg/day)
- Registration Number
- NCT05271838
- Lead Sponsor
- University of Aarhus
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Magnesium Magnesium acetate mixture (30 mmol/ml) Magnesium oral supplementation High protein diet High-protein diet (2 g/kg/day) High protein diet (2/g/kg/day)
- Primary Outcome Measures
Name Time Method 24 hour urine carbamide (mmol/d) 5 days Change in 24 hour urine carbamide (mmol/d) from baseline (day 0) to first follow-up (day 5)
- Secondary Outcome Measures
Name Time Method plasma carbamide (mmol/l) 0, follow-up 1 (day 5) and week 4 Change in plasma carbamide (mmol/l) measured at baseline, follow up 1(day 5) and at week 4.
24 hour urine carbamide (mmol/d) 4 weeks Change in 24 hour urine carbamide (mmol/d) between baseline (day 0) and at week 4
24 hour urine magnesium (mmol/d) 3 weeks Change in 24 hour urine magnesium (mmol/d) between follow up 1 (day 5) and after three weeks.
Fat free mass (FFM) (kg) 4 weeks Change in FFM (kg) between baseline and after four weeks. Measured after minimum 6 hours of fasting by Bioimpedance spectroscopy.
Fasting blood glucose (mmol/l) 4 weeks Change in fasting blood glucose (mmol/l) after a minimum of 6 hours fasting between baseline and week 4
Quality of life (QOL) questionaire (Hjortswang index) 3 weeks Change in QOL-score patient administered QOL-scoring system - Hjortswang index between follow-up 1 (day 5) and after three weeks.
plasma insulin (pmol/l) 4 weeks Change in plasma insulin (pmol/l) between baseline and week 4
Magnesium retention % 3 weeks Change in magnesium retention (%) between follow up 1 (day 5) until after three weeks.
Resting Energy Expenditure (REE) 4 weeks Change in REE between baseline and after four weeks. Measured after minimum 6 hours of fasting by indirect calorimetry.
plasma magnesium (mmol/l) 4 weeks Change in plasma magnesium (mmol/l) between follow-up 1 (day 5) and at week 4
plasma c-peptide (pmol/l) 4 weeks Change in plasma c-peptide (pmol/l) between baseline and week 4
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)-score 4 weeks Change in HOMA-IR-score between baseline and week 4
24 hour urine creatinine (mmol/d) 0, follow up 1 (day 5) and week 4 Change in 24 hour urine creatinine (mmol/d)
Quality of life (QOL) questionaire (SIBDQ) 3 weeks Change in QOL-score patient administered QOL-scoring system - The short bowel inflammatory bowel disease questionaire (SIBDQ) between follow-up 1 (day 5) and after three weeks.
Body weight (kg) 4 weeks Change in body between baseline and after four weeks. Measured after minimum 6 hours of fasting by Bioimpedance spectroscopy.
plasma albumin (g/L) 4 weeks Change in plasma albumin (mmol/l) between follow-up 1 (day 5) and at week 4
Creatinine-clearance (mL/min) 0, follow-up 1 (day 5) and week 4 Change in creatinine-clearance (ml/min)
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus N, Denmark