Magnesium in Gastrointestinal Disease

NCT07338565 | Recruiting

• 1 other identifier: 1-10-72-41-25
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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:
• Patients with inflammatory bowel disease.
• Patients with an ileostomy.
• Patients with bile acid diarrhoea.
• Healthy individuals (control group).

Conditions

Colitis Ulcerosa; Colitis Ulcerative; Crohns Disease; Morbus Crohn; Ileostomy - Stoma; Ileostoma; Ileostomies; Bile Acid Diarrhea; Bile Acid Malabsorption; Magnesium Deficiency; Magnesium Level; Magnesium

Outcome Measures

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%.

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

Secondary Outcomes (51)

• PBMC magnesium concentration

  Through study completion, an average of 5 weeks.

• RBC magnesium concentration

  Through study completion, an average of 5 weeks.

• Buffy coat magnesium concentration

  Through study completion, an average of 5 weeks.

• Intraindividual variability of PBMC magnesium (coefficient of variation)

  Through study completion, an average of 5 weeks.

• Intraindividual variability of RBC magnesium (coefficient of variation)

  Through study completion, an average of 5 weeks.

Study Arms (2)

Patients with an gastorintestinal disease or conditions

Patients with inflammatory bowel disease, ileostomy or bile acid diarrhoea

Healthy individuals (control group)

Healthy individuals (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \- 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.

You may not qualify if:

• Pregnant or breastfeeding.

Sponsors & Collaborators

• Aarhus University Hospital: collaborator
• University of Aarhus: lead

Study Sites (1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells (PBMC), buffy coat, red blood cells, muscle tissue, and intestinal mucosal biopsies (optional) will be retained for analysis of magnesium and related biomarkers. Although not intended for genetic testing, these samples contain genomic DNA.

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Magnesium Deficiency

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Mathias Redsted

CONTACT

+4530519619; matred@clin.au.dk

Christian L Hvas, Clinical professor, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 14, 2026
• Study Start: November 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-10

Locations

DK (1)