Protein and Magnesium in Ulcerative Colitis

NCT05271838 | Unknown

• 1 other identifier: 1-10-72-363-21
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Magnesium Deficiency; Nutritional Deficiency; Protein Deficiency

Outcome Measures

Primary Outcomes (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)

  5 days

Secondary Outcomes (17)

• 24 hour urine carbamide (mmol/d)

  4 weeks

• 24 hour urine creatinine (mmol/d)

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

• 24 hour urine magnesium (mmol/d)

  3 weeks

• Magnesium retention %

  3 weeks

• Quality of life (QOL) questionaire (SIBDQ)

  3 weeks

Other Outcomes (3)

• Protein intake (g/kg/day)

  Week 1 and week 4

• Energy intake (kcal/day)

  Week 1 and week 4

• Physical activity level (hours/week)

  4 weeks

Study Arms (4)

High protein diet

EXPERIMENTAL

High protein diet (2/g/kg/day)

Dietary Supplement: High-protein diet (2 g/kg/day)

Standard Nutritional care

NO INTERVENTION

Standard nutritional care.

Magnesium

EXPERIMENTAL

Magnesium oral supplementation

Dietary Supplement: Magnesium acetate mixture (30 mmol/ml)

Standard: No magnesium supplementation

NO INTERVENTION

No supplementation

Interventions

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.

Magnesium

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.

High protein diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnant and/or lactating women
• Plasma creatinine \> 200 µmol/L (protein intervention only)
• Patients receiving tube- or parenteral feeding (protein intervention only)
• Diagnosed with Type 1 or Type 2 Diabetes Mellitus (observational part only)

Sponsors & Collaborators

• University of Aarhus: lead
• University of Copenhagen: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Magnesium Deficiency; Malnutrition; Protein Deficiency

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Christian L Hvas, MD PhD

CONTACT

+4528351839; christian.hvas@auh.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 9, 2022
• Study Start: February 8, 2022
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

DK (1)