Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency.

NCT ID: NCT07236788

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-03-30

Brief Summary

This study aimed to explore the effects of preoperative intravenous isomaltose iron supplementation versus placebo on postoperative Hb improvement, prevention of postoperative anemia, and improvement in quality of life in patients undergoing bariatric surgery.

Conditions

Obesity; Anemia; Iron Deficiencies; Bariatric Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group

3±1 days before the operation, intravenous infusion of isomaltose iron injection was administered. The dosage was in accordance with the drug instructions. The maximum single infusion dose was 20mg/kg. If the dose could not be made up in one infusion, the remaining dose should be made up every other week.

Group Type: EXPERIMENTAL

Iron Isomaltoside injection

Intervention Type: DRUG

Patients in the isomaltan iron group received intravenous isomaltan iron dissolved in 250 ml of normal saline 3 days prior to surgery. The patients' iron requirements were calculated using a simplified scale, with a maximum single dose of 20 mg/kg. If the dose was insufficient in a single administration, a second infusion was required every other week. The placebo group received an equal volume of 0.9% normal saline.

Simplified scale:

Hemoglobin (g/L) patient weight <50kg 50-70kg >70kg

≥100 500mg 1000mg 1500mg <100 500mg 1500mg 2000mg

Placebo group

At the same time point, the same dose of physiological saline was infused.

Group Type: PLACEBO_COMPARATOR

Physiological saline solution (as placebo)

Intervention Type: DRUG

At the same time point, the same dose of physiological saline was infused as the experimental group.

Interventions

Iron Isomaltoside injection

Patients in the isomaltan iron group received intravenous isomaltan iron dissolved in 250 ml of normal saline 3 days prior to surgery. The patients' iron requirements were calculated using a simplified scale, with a maximum single dose of 20 mg/kg. If the dose was insufficient in a single administration, a second infusion was required every other week. The placebo group received an equal volume of 0.9% normal saline.

Simplified scale:

Hemoglobin (g/L) patient weight <50kg 50-70kg >70kg

≥100 500mg 1000mg 1500mg <100 500mg 1500mg 2000mg

Intervention Type: DRUG

Physiological saline solution (as placebo)

At the same time point, the same dose of physiological saline was infused as the experimental group.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ① Baseline Hb: Men 10-14 g/dL, Women 10-13 g/dL; ② Iron deficiency: Serum ferritin (SF) <100 μg/L, and transferrin saturation (TSAT) <20%; ③ BMI >30 kg/m2.

Exclusion Criteria

• ① Known severe hypersensitivity reactions to other parenteral iron supplements; ② Mean corpuscular volume (MCV) > 100 fL; ③ Received intravenous iron infusion within the past 3 months; ④ Concurrent tumors; ⑤ Concurrent iron overload or other hematologic disorders; ⑥ Concurrent infectious diseases such as hepatitis B; ⑦ Moderately impaired liver function: decompensated cirrhosis or hepatitis, ALT, AST > 3 × upper limit of normal (ULN); ⑧ Concurrent acute or chronic infections, heart failure, or other diseases affecting iron metabolism; ⑨ Patients with stage 3 or higher chronic renal insufficiency: glomerular filtration rate (eGFR) < 60 ml/min; ⑩ Pregnant or lactating women; ⑪ Acute infections, rheumatoid arthritis, or significant joint inflammation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hua Meng

Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

China-Japan Friendship Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Nianrong Zhang Zhang

Role: CONTACT

znrsd@163.com

+86 188 1048 8650

Facility Contacts

Nianrong Zhang

Role: primary

znrsd@163.com

+86 188 1048 8650

Other Identifiers

2024-HX-133

Identifier Type: -

Identifier Source: org_study_id