Clinical trial NCT05271838: Protein and Magnesium in Ulcerative Colitis
Official title: Nutritional Therapy for Patients With Acute Severe Ulcerative Colitis (ASUC) Treated With High-dose Steroids - a Special Focus on Protein and Magnesium.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Colitis, Ulcerative
Magnesium Deficiency
Nutritional Deficiency
Protein Deficiency
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2022-03-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At baseline patients are randomized to either a dietary protein intake of 2 g/kg/day (achieved by nutritional counseling and protein supplementations) or standard care (No nutritional counseling or protein recommendation are given) under admission and three weeks after discharge.

Furthermore patients with a magnesium retention level \>25% are further randomized to receive either magnesium acetate oral mixture (0,5 mmol/ml) 20 ml x 3 daily (30 mmol/day) or not receiving magnesium supplement for three weeks.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: 24 hour urine carbamide (mmol/d)
timeFrame: 5 days
Secondary outcomes:
measure: 24 hour urine carbamide (mmol/d)
timeFrame: 4 weeks
measure: 24 hour urine creatinine (mmol/d)
timeFrame: 0, follow up 1 (day 5) and week 4
measure: 24 hour urine magnesium (mmol/d)
timeFrame: 3 weeks
measure: Magnesium retention %
timeFrame: 3 weeks
measure: Quality of life (QOL) questionaire (SIBDQ)
timeFrame: 3 weeks
measure: Quality of life (QOL) questionaire (Hjortswang index)
timeFrame: 3 weeks
measure: Fat free mass (FFM) (kg)
timeFrame: 4 weeks
measure: Resting Energy Expenditure (REE)
timeFrame: 4 weeks
measure: Body weight (kg)
timeFrame: 4 weeks
measure: plasma carbamide (mmol/l)
timeFrame: 0, follow-up 1 (day 5) and week 4
measure: plasma magnesium (mmol/l)
timeFrame: 4 weeks
measure: plasma albumin (g/L)
timeFrame: 4 weeks
measure: plasma insulin (pmol/l)
timeFrame: 4 weeks
measure: plasma c-peptide (pmol/l)
timeFrame: 4 weeks
measure: Fasting blood glucose (mmol/l)
timeFrame: 4 weeks
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)-score
timeFrame: 4 weeks
measure: Creatinine-clearance (mL/min)
timeFrame: 0, follow-up 1 (day 5) and week 4
Other outcomes:
measure: Protein intake (g/kg/day)
timeFrame: Week 1 and week 4
measure: Energy intake (kcal/day)
timeFrame: Week 1 and week 4
measure: Physical activity level (hours/week)
timeFrame: 4 weeks
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: