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Inflammatory Bowel DiseasesPAMUCNCT05271838

Protein and Magnesium in Ulcerative Colitis

A study testing Magnesium acetate mixture (30 mmol/ml) and High-protein diet (2 g/kg/day) in people with Inflammatory Bowel Diseases and Colitis, Ulcerative, run by University of Aarhus at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Magnesium acetate mixture (30 mmol/ml) and High-protein diet (2 g/kg/day)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteDenmark
Study dates
8 Feb 2022to 1 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Christian L Hvas, MD PhD contact

+4528351839

christian.hvas@auh.rm.dk

Denmark1 site, 1 recruiting

  • Aarhus University Hospital

    Aarhus N, 8200

    Christian L Hvas, MD PhD, +45 28351839, christian.hvas@auh.rm.dk

    Recruiting

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
Magnesium acetate mixture (30 mmol/ml), High-protein diet (2 g/kg/day)
Medical subject headings
Inflammatory Bowel Diseases, Colitis, Ulcerative, Magnesium Deficiency, Malnutrition, Protein Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium acetate mixture (30 mmol/ml)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.

  • High-protein diet (2 g/kg/day)Dietary supplement

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

Study groups in NCT05271838
Study groupRoleWhat they receive
High protein dietExperimentalHigh protein diet (2/g/kg/day)
Receives: Dietary Supplement: High-protein diet (2 g/kg/day)
Standard Nutritional careNo interventionStandard nutritional care.
MagnesiumExperimentalMagnesium oral supplementation
Receives: Dietary Supplement: Magnesium acetate mixture (30 mmol/ml)
Standard: No magnesium supplementationNo interventionNo supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24 hour urine carbamide (mmol/d)

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

    Measured: 5 days

Secondary outcomes (17)

  1. 24 hour urine carbamide (mmol/d)

    Change in 24 hour urine carbamide (mmol/d) between baseline (day 0) and at week 4

    Measured: 4 weeks

  2. 24 hour urine creatinine (mmol/d)

    Change in 24 hour urine creatinine (mmol/d)

    Measured: 0, follow up 1 (day 5) and week 4

  3. 24 hour urine magnesium (mmol/d)

    Change in 24 hour urine magnesium (mmol/d) between follow up 1 (day 5) and after three weeks.

    Measured: 3 weeks

  4. Magnesium retention %

    Change in magnesium retention (%) between follow up 1 (day 5) until after three weeks.

    Measured: 3 weeks

  5. 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.

    Measured: 3 weeks

  6. 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.

    Measured: 3 weeks

  7. 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.

    Measured: 4 weeks

  8. Resting Energy Expenditure (REE)

    Change in REE between baseline and after four weeks. Measured after minimum 6 hours of fasting by indirect calorimetry.

    Measured: 4 weeks

  9. Body weight (kg)

    Change in body between baseline and after four weeks. Measured after minimum 6 hours of fasting by Bioimpedance spectroscopy.

    Measured: 4 weeks

  10. plasma carbamide (mmol/l)

    Change in plasma carbamide (mmol/l) measured at baseline, follow up 1(day 5) and at week 4.

    Measured: 0, follow-up 1 (day 5) and week 4

  11. plasma magnesium (mmol/l)

    Change in plasma magnesium (mmol/l) between follow-up 1 (day 5) and at week 4

    Measured: 4 weeks

  12. plasma albumin (g/L)

    Change in plasma albumin (mmol/l) between follow-up 1 (day 5) and at week 4

    Measured: 4 weeks

  13. plasma insulin (pmol/l)

    Change in plasma insulin (pmol/l) between baseline and week 4

    Measured: 4 weeks

  14. plasma c-peptide (pmol/l)

    Change in plasma c-peptide (pmol/l) between baseline and week 4

    Measured: 4 weeks

  15. Fasting blood glucose (mmol/l)

    Change in fasting blood glucose (mmol/l) after a minimum of 6 hours fasting between baseline and week 4

    Measured: 4 weeks

  16. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)-score

    Change in HOMA-IR-score between baseline and week 4

    Measured: 4 weeks

  17. Creatinine-clearance (mL/min)

    Change in creatinine-clearance (ml/min)

    Measured: 0, follow-up 1 (day 5) and week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start8 Feb 2022
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion1 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05271838
Sponsor's protocol ID
1-10-72-363-21
Acronym
PAMUC
Status last verified
Feb 2022
First submitted
17 Feb 2022
Last updated
9 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Magnesium acetate mixture (30 mmol/ml) and High-protein diet (2 g/kg/day) in people with Inflammatory Bowel Diseases and Colitis, Ulcerative, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christian L Hvas, MD PhD (+4528351839, christian.hvas@auh.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24 hour urine carbamide (mmol/d) (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05271838.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.

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