Protein and Magnesium in Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2022-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Magnesium in Gastrointestinal Disease

NCT07338565

Colitis Ulcerosa Colitis Ulcerative Crohns Disease +9 more

RECRUITING

Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease

NCT02801240

Colitis, Ulcerative Crohn's Disease

COMPLETED NA

Assessment of Nutritional Knowledge in Patients With Inflammatory Bowel Disease

NCT04882566

Ulcerative Colitis Crohn Disease Nutrition

UNKNOWN

Effects of Gluten Free Diet in Ulcerative Colitis

NCT06249763

Inflammatory Bowel Diseases Ulcerative Colitis

COMPLETED NA

Diagnostic Performance of Controlling Nutritional Status as a Nutritional Screening Tool in Patients With Inflammatory Bowel Disease

NCT06648551

Inflammatory Bowel Disease 5

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Diseases Colitis, Ulcerative Magnesium Deficiency Nutritional Deficiency Protein Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High protein diet

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Standard Nutritional care

Standard nutritional care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Magnesium

Magnesium oral supplementation

Group Type EXPERIMENTAL

Magnesium acetate mixture (30 mmol/ml)

Intervention Type 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.

Standard: No magnesium supplementation

No supplementation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No