Magnesium Status in Patients With Gastrointestinal Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of participants with magnesium deficiency (magnesium retention >20%)
研究概览
简要总结
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).
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.
详细描述
This cross-sectional study aims to improve the assessment of magnesium status in patients with chronic intestinal diseases. The study will evaluate and compare a range of biochemical and functional markers to determine which provide the most accurate, reliable, and clinically useful reflection of whole-body magnesium status. The long-term goal is to support the development of a more sensitive screening strategy for magnesium deficiency in clinical practice, especially for populations at increased risk due to gastrointestinal losses or malabsorption.
Magnesium deficiency is often underdiagnosed due to the limitations of standard plasma magnesium measurement. Although total body magnesium is primarily stored in bone and soft tissue, the current standard diagnostic method (plasma magnesium) reflects only a small fraction of total magnesium (<1%) and does not correlate well with intracellular magnesium content. As a result, many cases of subclinical or functional magnesium deficiency go undetected, particularly in populations with chronic gastrointestinal conditions that alter absorption and excretion.
Study Design and Rationale:
The study will consist of four visits and include two groups:
- Patients with gastrointestinal disease or conditions, divided into three subgroups: those with inflammatory bowel disease (IBD; Crohn's disease or ulcerative colitis), those with an ileostomy or patients with bile acid diarrhoea.
- Healthy controls without known gastrointestinal disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Age 18 or older, mentally competent, and able to understand Danish.
- •- 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%).
- •- Healthy individuals.
排除标准
- •Pregnant or breastfeeding.
- •Use of oral magnesium supplements for more than 2 weeks before inclusion.
研究组 & 干预措施
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)
结局指标
主要结局
Percentage of participants with magnesium deficiency (magnesium retention >20%)
时间窗: Immediately after completion of the magnesium infusion (Visit 3; urine collection completed within ~24 hours post-infusion).
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%.
次要结局
- 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.)
- Intraindividual variability of buffy coat magnesium (coefficient of variation)(Through study completion, an average of 5 weeks.)
- 24-hour urinary magnesium excretion (mmol/day)(Through study completion, an average of 5 weeks.)
- Skeletal muscle magnesium concentration(Visit 1 (Baseline).)
- Gut microbiota composition (relative abundance)(Visit 1 (Baseline))
- Bone mineral density (BMD) by DEXA (g/cm²)(Visit 1 (Baseline).)
- Plasma metabolic markers(Visit 1 (Baseline), Visit 2 (Day 2), Visit 3 (Day 3), and Visit 4 (end of study; 4 weeks after Visit 3).)
- Maximum handgrip strength (kg)(Visit 1 (Baseline).)
- SIBDQ score - Short Inflammatory Bowel Disease Questionnaire (10-70)(Visit 1 (Baseline) and Visit 4 (end of study; 4 weeks after Visit 3).)
- Estimated daily magnesium intake (MgFFQ) (mg/day)(Visit 1 (Baseline) and Visit 4 (end of study; 4 weeks after Visit 3).)
- Magnesium concentration in intestinal tissue(Visit 1 (Baseline).)
- Plasma hormonal markers(Visit 1 (Baseline), Visit 2 (Day 2), Visit 3 (Day 3) and Visit 4 (end of study; 4 weeks after Visit 3))
- Plasma creatinine(Visit 1 (Baseline), Visit 2 (Day 2), Visit 3 (Day 3) and Visit 4 (end of study; 4 weeks after Visit 3))
- Plasma inflammatory marker(Visit 1 (Baseline), Visit 2 (Day 2), Visit 3 (Day 3) and Visit 4 (end of study; 4 weeks after Visit 3))
- Plasma Renin(Visit 1 (Baseline), Visit 2 (Day 2), Visit 3 (Day 3) and Visit 4 (end of study; 4 weeks after Visit 3))
- Plasma Aldosterone(Visit 1 (Baseline), Visit 2 (Day 2), Visit 3 (Day 3) and Visit 4 (end of study; 4 weeks after Visit 3))
- Leukocyte differential count(Visit 1 (Baseline), Visit 2 (Day 2), Visit 3 (Day 3) and Visit 4 (end of study; 4 weeks after Visit 3))
- Urinary creatinine(Visit 2 (Day 2) and Visit 3 (Day 3))
- Urine volume(Visit 2 (Day 2) and Visit 3 (Day 3))
- 24-hour urinary acid-base excretion (mmol/day)(Visit 2 (Day 2))
- Creatinine clearance(Visit 2 (Day 2) and Visit 3 (Day 3))
- Faecal bicarbonate concentration(Visit 1 (Baseline).)
- Bone mineral content (BMC) by DEXA (g)(Visit 1 (Baseline).)
- Appendicular lean mass (ALM) (kg)(Visit 1 (Baseline).)
- Total lean mass by DEXA (kg)(Visit 1 (Baseline).)
- Total fat mass by DEXA (kg)(Visit 1 (Baseline).)
- BIS Resistance (R, Ω)(Visit 1 (Baseline).)
- 30-second Sit-to-Stand test (repetitions)(Visit 1 (Baseline).)
- BIS Reactance (Xc, Ω)(Visit 1 (Baseline).)
- Phase angle (degrees) by BIS (°)(Visit 1 (Baseline).)
- Total Body Water (TBW), Intracellular Water (ICW) and Extracellular Water (ECW) (liters)(Visit 1 (Baseline).)
- SBS-QoL score - Short Bowel Syndrome Quality of Life (0-100)(Visit 1 (Baseline) and Visit 4 (end of study; 4 weeks after Visit 3).)
- EQ-5D-5L index value.(Visit 1 (Baseline) and Visit 4 (end of study; 4 weeks after Visit 3).)
- IBD-Fatigue Scale total score (specify range used)(Visit 1 (Baseline) and Visit 4 (end of study; 4 weeks after Visit 3).)
- Harvey-Bradshaw Index (HBI) total score (Crohn's disease activity)(Visit 1 (Baseline) and Visit 4 (end of study; 4 weeks after Visit 3).)
- Simple Clinical Colitis Activity Index (SCCAI) total score(Visit 1 (Baseline) and Visit 4 (end of study; 4 weeks after Visit 3).)
- Visual analogue scale (VAS) for magnesium-deficiency symptoms (0-100 mm)(Visit 1 (Baseline) and Visit 4 (end of study; 4 weeks after Visit 3).)
- KRAM questionnaire composite scores (diet, smoking, alcohol, physical activity)(Visit 1 (Baseline) and Visit 4 (end of study; 4 weeks after Visit 3).)
- Intestinal tissue magnesium concentration(Visit 1 (Baseline).)
- Plasma electrolytes (mmol/L)(Through study completion, an average of 5 weeks.)
- Fasting plasma glucose (mmol/L)(Visit 1 (Baseline) and Visit 4 (end of study; 4 weeks after Visit 3).)
- Plasma albumin (g/L)(Through study completion, an average of 5 weeks.)
- Spot urine magnesium concentration (mmol/L)(Visit 2 (Day 2) and Visit 3 (Day 3))
- 24-hour urinary creatinine(Visit 2 (Day 2) and Visit 3 (Day 3))
- Spot urine acid-base parameters(Visit 2 (Day 2) and Visit 3 (Day 3))
- Serum acid-base status: bicarbonate, base excess, total CO₂(Visit 1 (Baseline).)
- Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²)(Visit 1 (Baseline).)