Protein and Magnesium in Ulcerative Colitis

University of Aarhus36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

Magnesium acetate mixture (30 mmol/ml)DIETARY_SUPPLEMENT

Patients with a magnesium retention test \>25% and randomized to intervention receive magnesium acetate oral mixture (30 mmol/ml) 20 ml x 3/day for a period of three weeks.

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

Nutritional counseling and protein supplementation to establish an intake of 2 g protein kg/day during admission and three weeks after discharge.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

24 hour urine carbamide (mmol/d)

Change in 24 hour urine carbamide (mmol/d) from baseline (day 0) to first follow-up (day 5)

Time frame: 5 days

Secondary Outcomes

24 hour urine carbamide (mmol/d)

Change in 24 hour urine carbamide (mmol/d) between baseline (day 0) and at week 4

Time frame: 4 weeks

24 hour urine creatinine (mmol/d)

Change in 24 hour urine creatinine (mmol/d)

Time frame: 0, follow up 1 (day 5) and week 4

24 hour urine magnesium (mmol/d)

Change in 24 hour urine magnesium (mmol/d) between follow up 1 (day 5) and after three weeks.

Time frame: 3 weeks

Magnesium retention %

Change in magnesium retention (%) between follow up 1 (day 5) until after three weeks.

Time frame: 3 weeks

Quality of life (QOL) questionaire (SIBDQ)

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.

Time frame: 3 weeks

Quality of life (QOL) questionaire (Hjortswang index)

Change in QOL-score patient administered QOL-scoring system - Hjortswang index between follow-up 1 (day 5) and after three weeks.

Time frame: 3 weeks

Fat free mass (FFM) (kg)

Change in FFM (kg) between baseline and after four weeks. Measured after minimum 6 hours of fasting by Bioimpedance spectroscopy.

Time frame: 4 weeks

Resting Energy Expenditure (REE)

Change in REE between baseline and after four weeks. Measured after minimum 6 hours of fasting by indirect calorimetry.

Time frame: 4 weeks

Body weight (kg)

Change in body between baseline and after four weeks. Measured after minimum 6 hours of fasting by Bioimpedance spectroscopy.

Time frame: 4 weeks

plasma carbamide (mmol/l)

Change in plasma carbamide (mmol/l) measured at baseline, follow up 1(day 5) and at week 4.

Time frame: 0, follow-up 1 (day 5) and week 4

plasma magnesium (mmol/l)

Change in plasma magnesium (mmol/l) between follow-up 1 (day 5) and at week 4

Time frame: 4 weeks

plasma albumin (g/L)

Change in plasma albumin (mmol/l) between follow-up 1 (day 5) and at week 4

Time frame: 4 weeks

plasma insulin (pmol/l)

Change in plasma insulin (pmol/l) between baseline and week 4

Time frame: 4 weeks

plasma c-peptide (pmol/l)

Change in plasma c-peptide (pmol/l) between baseline and week 4

Time frame: 4 weeks

Fasting blood glucose (mmol/l)

Change in fasting blood glucose (mmol/l) after a minimum of 6 hours fasting between baseline and week 4

Time frame: 4 weeks

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)-score

Change in HOMA-IR-score between baseline and week 4

Time frame: 4 weeks

Creatinine-clearance (mL/min)

Change in creatinine-clearance (ml/min)

Time frame: 0, follow-up 1 (day 5) and week 4

Protein and Magnesium in Ulcerative Colitis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts