Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency.
NCT07236788 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-11-19
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
Interventions
- 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.
Sponsors & Collaborators
-
China-Japan Friendship Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-01
- Primary Completion
- 2026-12-30
- Completion
- 2027-03-30
Countries
- China
Study Locations
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