Protein and Magnesium in Ulcerative Colitis

Phase

N/A

Condition

Diet And Nutrition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

N/A

Clinical Study ID

NCT05271838

1-10-72-363-21

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 18 years or older
Cognizant
Must speak or read Danish or participate in relevant communication in interpreting ortranslating the study material.
Diagnosed with Acute Severe Ulcerative Colitis (ASUC) (documented in the patientjournal)
Admitted at "Lever-, Mave-, og Tarmsygdomme/ LMT" at Aarhus University Hospital and inmedical treatment with high-dose intravenous steroid (Solumedrol 40 mg x 2 daily)

Exclusion

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 (magnesiumintervention only)
Diagnosed with Type 1 or Type 2 Diabetes Mellitus (observational part only)

Study Design

February 08, 2022

July 01, 2022

Study 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.

Connect with a study center

Aarhus University Hospital
Aarhus N, 8200
Denmark
Active - Recruiting

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