Magnesium in Gastrointestinal Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Aarhus

About this trial

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

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Pregnant or breastfeeding.

Use of oral magnesium supplements for more than 2 weeks before inclusion.

Trial population

Patients will primarily be recruited from both inpatient and outpatient clinics from the Department of Hepatology and Gastroenterology at Aarhus University Hospital, as well as through patient associations (Colitis-Crohn Association and the Danish Stoma Association). Healthy individuals will be recruited through online platforms/social media and local hospital networks.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: Patients with an gastorintestinal disease or conditions
Group B: Healthy individuals (control group)

Trial outcomes

Primary outcomes

1

Percentage of participants with magnesium deficiency (magnesium retention >20%)

Proportion of participants whose magnesium retention rate exceeds 20%, where retention (%) = (infused magnesium - urinary magnesium excretion) / infused magnesium × 100. Unit: percent (%). Threshold for deficiency: retention \>20%.

Time frame
Immediately after completion of the magnesium infusion (Visit 3; urine collection completed within ~24 hours post-infusion).

Secondary outcomes

1

PBMC magnesium concentration

Total magnesium concentration in peripheral blood mononuclear cells (PBMC). Units: nmol/10⁶ cells.

Time frame
Through study completion, an average of 5 weeks.
2

RBC magnesium concentration

Magnesium concentration in red blood cells (RBC). Units: nmol/10⁶ cells.

Time frame
Through study completion, an average of 5 weeks.
3

Buffy coat magnesium concentration

Total magnesium concentration in the buffy coat fraction. Units: nmol/10⁶ cells.

Time frame
Through study completion, an average of 5 weeks.
4

Intraindividual variability of PBMC magnesium (coefficient of variation)

Within-subject coefficient of variation (CV%) for PBMC magnesium

Time frame
Through study completion, an average of 5 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Aarhus University Hospital

Collaborator