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Recruiting Not applicable

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

NCT07236788 · tracked via the Priya Life Science Japan tracker
Phase
Not applicable
Started
2025-03-01
Last updated
2025-11-19

Condition(s) studied

ObesityAnemiaIron DeficienciesBariatric Surgery

Investigational drug(s) / intervention(s)

Iron Isomaltoside injectionPhysiological saline solution (as placebo)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • changes in Hb concentration compared to baseline — 3 months post-surgery,

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07236788 on ClinicalTrials.gov ↗ ← All trials in Japan