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Protein and Magnesium in Ulcerative Colitis (PAMUC)

Primary Purpose

Inflammatory Bowel Diseases, Colitis, Ulcerative, Magnesium Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Magnesium acetate mixture (30 mmol/ml)
High-protein diet (2 g/kg/day)
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

High protein diet

Standard Nutritional care

Magnesium

Standard: No magnesium supplementation

Arm Description

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

Standard nutritional care.

Magnesium oral supplementation

No supplementation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2022
Last Updated
February 27, 2022
Sponsor
University of Aarhus
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT05271838
Brief Title
Protein and Magnesium in Ulcerative Colitis
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Colitis, Ulcerative, Magnesium Deficiency, Nutritional Deficiency, Protein Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
At baseline patients are randomized to either a dietary protein intake of 2 g/kg/day (achieved by nutritional counseling and protein supplementations) or standard care (No nutritional counseling or protein recommendation are given) under admission and three weeks after discharge. Furthermore patients with a magnesium retention level >25% are further randomized to receive either magnesium acetate oral mixture (0,5 mmol/ml) 20 ml x 3 daily (30 mmol/day) or not receiving magnesium supplement for three weeks.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High protein diet
Arm Type
Experimental
Arm Description
High protein diet (2/g/kg/day)
Arm Title
Standard Nutritional care
Arm Type
No Intervention
Arm Description
Standard nutritional care.
Arm Title
Magnesium
Arm Type
Experimental
Arm Description
Magnesium oral supplementation
Arm Title
Standard: No magnesium supplementation
Arm Type
No Intervention
Arm Description
No supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium acetate mixture (30 mmol/ml)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
High-protein diet (2 g/kg/day)
Intervention Description
Nutritional counseling and protein supplementation to establish an intake of 2 g protein kg/day during admission and three weeks after discharge.
Primary Outcome Measure Information:
Title
24 hour urine carbamide (mmol/d)
Description
Change in 24 hour urine carbamide (mmol/d) from baseline (day 0) to first follow-up (day 5)
Time Frame
5 days
Secondary Outcome Measure Information:
Title
24 hour urine carbamide (mmol/d)
Description
Change in 24 hour urine carbamide (mmol/d) between baseline (day 0) and at week 4
Time Frame
4 weeks
Title
24 hour urine creatinine (mmol/d)
Description
Change in 24 hour urine creatinine (mmol/d)
Time Frame
0, follow up 1 (day 5) and week 4
Title
24 hour urine magnesium (mmol/d)
Description
Change in 24 hour urine magnesium (mmol/d) between follow up 1 (day 5) and after three weeks.
Time Frame
3 weeks
Title
Magnesium retention %
Description
Change in magnesium retention (%) between follow up 1 (day 5) until after three weeks.
Time Frame
3 weeks
Title
Quality of life (QOL) questionaire (SIBDQ)
Description
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
Title
Quality of life (QOL) questionaire (Hjortswang index)
Description
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
Title
Fat free mass (FFM) (kg)
Description
Change in FFM (kg) between baseline and after four weeks. Measured after minimum 6 hours of fasting by Bioimpedance spectroscopy.
Time Frame
4 weeks
Title
Resting Energy Expenditure (REE)
Description
Change in REE between baseline and after four weeks. Measured after minimum 6 hours of fasting by indirect calorimetry.
Time Frame
4 weeks
Title
Body weight (kg)
Description
Change in body between baseline and after four weeks. Measured after minimum 6 hours of fasting by Bioimpedance spectroscopy.
Time Frame
4 weeks
Title
plasma carbamide (mmol/l)
Description
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
Title
plasma magnesium (mmol/l)
Description
Change in plasma magnesium (mmol/l) between follow-up 1 (day 5) and at week 4
Time Frame
4 weeks
Title
plasma albumin (g/L)
Description
Change in plasma albumin (mmol/l) between follow-up 1 (day 5) and at week 4
Time Frame
4 weeks
Title
plasma insulin (pmol/l)
Description
Change in plasma insulin (pmol/l) between baseline and week 4
Time Frame
4 weeks
Title
plasma c-peptide (pmol/l)
Description
Change in plasma c-peptide (pmol/l) between baseline and week 4
Time Frame
4 weeks
Title
Fasting blood glucose (mmol/l)
Description
Change in fasting blood glucose (mmol/l) after a minimum of 6 hours fasting between baseline and week 4
Time Frame
4 weeks
Title
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)-score
Description
Change in HOMA-IR-score between baseline and week 4
Time Frame
4 weeks
Title
Creatinine-clearance (mL/min)
Description
Change in creatinine-clearance (ml/min)
Time Frame
0, follow-up 1 (day 5) and week 4
Other Pre-specified Outcome Measures:
Title
Protein intake (g/kg/day)
Description
Assessment of dietary protein intake during admission and after discharge by patient dietary registration schedules and supplemented by 24-h recall during admission.
Time Frame
Week 1 and week 4
Title
Energy intake (kcal/day)
Description
Assessment of dietary intake during admission and after discharge by patient dietary registration schedules and supplemented by 24-h recall during admission.
Time Frame
Week 1 and week 4
Title
Physical activity level (hours/week)
Description
Patients are asked about habitual physical activity level (hours/week) in the period before admission and physical activity level within 3 weeks after discharge.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian L Hvas, MD PhD
Phone
+4528351839
Email
christian.hvas@auh.rm.dk
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian L Hvas, MD PhD
Phone
+45 28351839
Email
christian.hvas@auh.rm.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Protein and Magnesium in Ulcerative Colitis

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