Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency.
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Obesity, Anemia, Iron Deficiencies, Bariatric Surgery
In brief
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.
Key facts
- Study ID
- NCT07236788
- Run by
- China-Japan Friendship Hospital
- People needed
- 200
- Starts
- 2025-03-01
- Expected to finish
- 2027-03-30
- Last updated by the study team
- 2025-11-19
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- China-Japan Friendship Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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