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

NCT07236788 | Recruiting

• 1 other identifier: 2024-HX-133
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• changes in Hb concentration compared to baseline

  3 months post-surgery,

Secondary Outcomes (3)

• 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

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

At the same time point, the same dose of physiological saline was infused.

Drug: Physiological saline solution (as placebo)

Interventions

Iron Isomaltoside injection DRUG

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

Treatment group

Physiological saline solution (as placebo) DRUG

At the same time point, the same dose of physiological saline was infused as the experimental group.

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Obesity; Anemia; Iron Deficiencies

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases

Central Study Contacts

Nianrong Zhang Zhang

CONTACT

+86 188 1048 8650; znrsd@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 19, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CN (1)