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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Anemia; Bariatric Surgery; Iron Deficiencies
• Intervention / Treatment: Drug: Iron Isomaltoside injection; Drug: Physiological saline solution (as placebo)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nianrong Zhang Zhang; Phone Number: +86 188 1048 8650; Email: znrsd@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: Nianrong Zhang; Phone Number: +86 188 1048 8650; Email: znrsd@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Placebo Comparator: Placebo group; At the same time point, the same dose of physiological saline was infused.	Drug: Physiological saline solution (as placebo); At the same time point, the same dose of physiological saline was infused as the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes in Hb concentration compared to baseline	3 months post-surgery,

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of anemia	3 months, 6 months and 12 months after surgery
Iron metabolism indicators (serum ferritin, serum iron, total iron binding capacity, transferrin saturation)	3 months, 6 months, and 12 months post-surgery
The proportion of patients requiring re-treatment for iron deficiency anemia within 12 months post-surgery (Hb < 11 g/dL, SF < 30 μg/L, or SF < 100 μg/L and TSAT < 20%).	12 months post-surgery

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Hematologic Diseases; Overweight; Iron Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Hemic and Lymphatic Diseases; Iron Deficiencies; Obesity; Anemia; iron isomaltoside 1000
• Other Study ID Numbers: 2024-HX-133

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No