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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05271838
Other study ID # 1-10-72-363-21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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