Oral Versus Intravenous Iron in IBD Patients With Anti-inflammatory Therapy.

NCT05581420 | Unknown

• 1 other identifier: NL79363.058.21
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Iron deficiency anemia is the most common systemic manifestation of Inflammatory Bowel Diseases (IBD)-Crohn's disease and ulcerative colitis. Iron deficiency with or without anemia poses a diagnostic and therapeutic challenge due to chronic gastrointestinal blood loss and the inflammatory nature of IBD. Oral iron supplementation in active disease states is controversial. Hepcidin levels can be considered as the sum effect of all regulatory processes. Studies suggested that iron stores and hypoxia reduce hepcidin levels even in an inflammatory state. This is also reflected by a study which demonstrated low levels of hepcidin in patients with ferritin levels under 30μg/ml, regardless of disease activity or type. Furthermore, studies show that immunosuppressive medication decrease the level of hepcidin. This raises the question: is oral iron a viable alternative for patients under immunosuppressive treatment for active IBD? Objective: The hypothesis is that patients with mild to moderate IBD activity on immunosuppressive medication, show the same level of Hb increase after 12 weeks after either oral or iv iron supplementation, while the price of oral iron supplementation is significantly lower.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Normalization of Hb concentration (> 7.3 mmol/L (females) or > 8.0 mmol/L (males)) from baseline to week 12 in both oral and iv iron supplementation group.

  Percentage of patients who achieved an adequate hematologic response (defined by Hb \> 7.3 mmol/L (females) or \> 8.0 mmol/L (males)) after 12 weeks

  After 12 weeks

Secondary Outcomes (13)

• Change in Hb levels

  baseline, weeks 4, 12 and 16

• percentage of participants with ferritin levels > 100 microg/l

  after 4, 12 and 16 weeks

• Preference of patient for oral versus i.v. iron

  at baseline and at week 16

• Change in Disease-specific Quality of life (IBDQ)

  at week 16 in comparison with baseline

• Change in overall/generic Quality of life (EQ-5D-5L)

  at week 16 in comparison with baseline

Study Arms (2)

Oral iron

ACTIVE COMPARATOR

Ferrous fumarate 200mg daily for 4 weeks. Group A1 (Normal Hb at week 4): Ferrous fumarate 100mg daily for 12 weeks Group A2 (Abnormal Hb at week 4): Ferrous fumarate 200mg daily for 8 weeks Group A2 at week 12: Normal Hb: ferrous fumarate 100 mg daily till week 16 Abnormal Hb: intervention failure. End of study.

Drug: Ferrous fumarate

IV Iron

ACTIVE COMPARATOR

Dosage based on iron formulation and instructions according to recommended guidelines (weight of patient)

Drug: MonoFer

Interventions

Ferrous fumarate DRUG

Patients randomized in the oral group, will all be prescribed ferrous fumarate 200 mg d.d. for the first 4 weeks. Then, depending on their iron status, 100 mg d.d. for the following 12 weeks or 4 more weeks 200 mg d.d. followed by 4 weeks 100 mg d.d.. If iron levels are still too low after 12 weeks, the intervention has failed.

Oral iron

MonoFer DRUG

Study patients will be treated with intravenous iron. The brand name of the iv iron is dependent on the hospital policy and the doses will be according to recommended guidelines (weight of patient). Iv iron is intramural medication without add-on status and needs infusion at daycare.

Also known as: Ferinject, Cosmofer, Venofer

IV Iron

Eligibility Criteria

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

You may qualify if:

• Established IBD diagnosis (Crohn's disease, ulcerative colitis, IBD-unclassified)
• Adults (≥18 years of age)
• Any single Hb level between 6,2 - 7,3 mmol/L (females) 6,2 - 8,0 mmol/L (males)
• CRP \> 5 mg/L and / or fecal calprotectin \> 150 within 4 weeks of randomization
• Patients on immunosuppressive medication (thiopurine, methotrexate, biologicals, JAK inhibitor) for at least 8 weeks or if prednisone, for at least 2 weeks
• Mild to moderate disease according to the treating physician; a Physician Global Assessment (PGA) score of 1 or 2
• Documented informed consent

You may not qualify if:

• Anemia due to reasons other than iron deficiency or chronic disease (e.g. hemoglobinopathy).
• Severe disease with a PGA score of 3
• IBD patients with a location of IBD at other places than ileum and / or colon (according to treating physician)
• Patients who are prescribed PPI
• Earlier significant side effect of oral iron or iv iron
• Folic acid deficiency (\<2.5 μg/ml)
• Vitamin B12 deficiency (\<150 mg/l)
• Documented history of bariatric surgery or gastric/duodenal resections due to benign or malignant pathologies
• Documented history of liver cirrhosis, heart failure, hemoglobinopathies, autoimmune hemolytic anemia, myelodysplastic syndrome, or chronic obstructive pulmonary disease (COPD)
• End-stage renal disease (impaired renal function, defined as eGFR \<30 ml/min/1.73m2)

Sponsors & Collaborators

• Leiden University Medical Center: lead
• University Medical Center Groningen: collaborator
• UMC Utrecht: collaborator
• Rijnstate Hospital: collaborator
• Erasmus Medical Center: collaborator
• Sint Franciscus Gasthuis: collaborator
• Adrz, Goes: collaborator
• Medical Center Haaglanden: collaborator

Study Sites (1)

Leiden University Medical Centre

Leiden, South Holland, 2300 RC, Netherlands

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

ferrous fumarate; ferric carboxymaltose; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• A.E. van der Meulen - de Jong, MD, PhD

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

L.J.M. Koppelman, Msc.

CONTACT

0031715297902; patientenibd@lumc.nl

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: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: October 14, 2022
• Study Start: June 2, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

NL (1)