Protein and Magnesium in Ulcerative Colitis (PAMUC)

Nutritional Therapy for Patients With Acute Severe Ulcerative Colitis (ASUC) Treated With High-dose Steroids - a Special Focus on Protein and Magnesium.

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Colitis, Ulcerative; Magnesium Deficiency; Nutritional Deficiency; Protein Deficiency
• Intervention / Treatment: Dietary supplement: High-protein diet (2 g/kg/day); Dietary supplement: Magnesium acetate mixture (30 mmol/ml)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High protein diet; High protein diet (2/g/kg/day)	Dietary supplement: High-protein diet (2 g/kg/day); Nutritional counseling and protein supplementation to establish an intake of 2 g protein kg/day during admission and three weeks after discharge.
No Intervention: Standard Nutritional care; Standard nutritional care.
Experimental: Magnesium; Magnesium oral supplementation	Dietary supplement: Magnesium acetate mixture (30 mmol/ml); 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.
No Intervention: Standard: No magnesium supplementation; No supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour urine carbamide (mmol/d)	Change in 24 hour urine carbamide (mmol/d) from baseline (day 0) to first follow-up (day 5)	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour urine carbamide (mmol/d)	Change in 24 hour urine carbamide (mmol/d) between baseline (day 0) and at week 4	4 weeks
24 hour urine creatinine (mmol/d)	Change in 24 hour urine creatinine (mmol/d)	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.	3 weeks
Magnesium retention %	Change in magnesium retention (%) between follow up 1 (day 5) until after three weeks.	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.	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.	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.	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.	4 weeks
Body weight (kg)	Change in body between baseline and after four weeks. Measured after minimum 6 hours of fasting by Bioimpedance spectroscopy.	4 weeks
plasma carbamide (mmol/l)	Change in plasma carbamide (mmol/l) measured at baseline, follow up 1(day 5) and at week 4.	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	4 weeks
plasma albumin (g/L)	Change in plasma albumin (mmol/l) between follow-up 1 (day 5) and at week 4	4 weeks
plasma insulin (pmol/l)	Change in plasma insulin (pmol/l) between baseline and week 4	4 weeks
plasma c-peptide (pmol/l)	Change in plasma c-peptide (pmol/l) between baseline and week 4	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	4 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)-score	Change in HOMA-IR-score between baseline and week 4	4 weeks
Creatinine-clearance (mL/min)	Change in creatinine-clearance (ml/min)	0, follow-up 1 (day 5) and week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein intake (g/kg/day)	Assessment of dietary protein intake during admission and after discharge by patient dietary registration schedules and supplemented by 24-h recall during admission.	Week 1 and week 4
Energy intake (kcal/day)	Assessment of dietary intake during admission and after discharge by patient dietary registration schedules and supplemented by 24-h recall during admission.	Week 1 and week 4
Physical activity level (hours/week)	Patients are asked about habitual physical activity level (hours/week) in the period before admission and physical activity level within 3 weeks after discharge.	4 weeks

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 27, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 27, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Nutrition Disorders; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Deficiency Diseases; Ulcer; Inflammatory Bowel Diseases; Malnutrition; Colitis; Colitis, Ulcerative; Magnesium Deficiency; Protein Deficiency
• Other Study ID Numbers: 1-10-72-363-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No