| NCT ID | NCT07338565 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Colitis Ulcerosa |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-11-03 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Individuals with gastrointestinal diseases - such as Crohn's disease, ulcerative colitis, ileostomy, or bile acid diarrhoea - are at increased risk of magnesium deficiency. Magnesium is a vital mineral that supports many essential functions in the body, including muscle contraction, nerve signalling, heart rhythm, and bone health. Deficiency may contribute to fatigue, muscle cramps, abnormal heart rhythms, and reduce the quality of life. The purpose of this study is to investigate the prevalence of magnesium deficiency in individuals with these conditions and to identify the most accurate and practical methods for assessing magnesium status in clinical care. Although plasma magnesium is commonly used in routine blood tests, it represents only about 1% of the body's total magnesium and may not reflect true magnesium levels within cells or tissues. Hence, this study compares several different ways of measuring magnesium, including: * Plasma magnesium * Magnesium levels in red and white blood cells (PBMC, RBC, and buffy coat) * Magnesium levels in muscle tissue (via biopsy) * A magnesium retention test, based on how much magnesium is excreted after an infusion The study includes four groups: 1. Patients with inflammatory bowel disease. 2. Patients with an ileostomy. 3. Patients with bile acid diarrhoea. 4. Healthy individuals (control group). All participants will provide blood and urine samples, and some may undergo optional biopsies of muscle or intestinal tissue. Participants will also complete questionnaires and undergo tests of muscle strength and body composition. The findings are expected to enhance the understanding and detection of magnesium deficiency in patients with gastrointestinal diseases and to aid in the development of more effective tools for identifying and treating this common yet often overlooked condition.
Eligibility Criteria
Inclusion Criteria: \- Age 18 or older, mentally competent, and able to understand Danish. Group 1: \- Diagnosed with IBD (DK50X, Crohn's disease, or DK51X, ulcerative colitis), ileostomy (DZ932) or bile acid diarrhoea (DSK908B) (Se-HCAT scintigraphy showing residual activity \<10%). Group 2: \- Healthy individuals. Exclusion Criteria: * Pregnant or breastfeeding. * Use of oral magnesium supplements for more than 2 weeks before inclusion.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07338565 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colitis Ulcerosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07338565 currently recruiting?
Yes, NCT07338565 is actively recruiting participants. Contact the research team at matred@clin.au.dk for enrollment information.
Where is the NCT07338565 trial being conducted?
This trial is being conducted at Aarhus N, Denmark.
Who is sponsoring the NCT07338565 clinical trial?
NCT07338565 is sponsored by University of Aarhus. The trial plans to enroll 120 participants.