Protein and Magnesium in Ulcerative Colitis

Inflammatory Bowel Diseases Clinical Trial

— PAMUC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271838
• Other study ID #: 1-10-72-363-21
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: February 2022
• Source: University of Aarhus
• Contact: Christian L Hvas, MD PhD
• Phone: +4528351839
• Email: christian.hvas[@]auh.rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Magnesium Deficiency
• Malnutrition
• Nutritional Deficiency
• Protein Deficiency
• Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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