Protein and Magnesium in Ulcerative Colitis (PAMUC)

University of Aarhus

Status: Unknown

Conditions: Protein Deficiency; Colitis, Ulcerative; Magnesium Deficiency; Nutritional Deficiency; Inflammatory Bowel Diseases

Treatments: Dietary Supplement: Magnesium acetate mixture (30 mmol/ml); Dietary Supplement: High-protein diet (2 g/kg/day)

Study type: Interventional

Funder types: Other

Identifiers

NCT05271838

1-10-72-363-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

High protein diet

Experimental group

Description:

High protein diet (2/g/kg/day)

Treatment:

Dietary Supplement: High-protein diet (2 g/kg/day)

Standard Nutritional care

No Intervention group

Description:

Standard nutritional care.

Magnesium

Experimental group

Description:

Magnesium oral supplementation

Treatment:

Dietary Supplement: Magnesium acetate mixture (30 mmol/ml)

Standard: No magnesium supplementation

No Intervention group

Description:

No supplementation