NCT07236788

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
DRUG	Physiological saline solution (as placebo)	At the same time point, the same dose of physiological saline was infused as the experimental group.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-12-30
• Completion: 2027-03-30
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: China