ObesityNCT07236788
Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency.
A study testing Iron Isomaltoside injection in people with Obesity and Anemia, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Anemia, Iron Deficiencies
- What is being tested?
- Iron Isomaltoside injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing
Nianrong Zhang, +86 188 1048 8650, znrsd@163.com
About this study
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
- Being tested
- Iron Isomaltoside injection, Physiological saline solution (as placebo)
- Medical subject headings
- Obesity, Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Isomaltoside injectionDrug
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)Drug
At the same time point, the same dose of physiological saline was infused as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Iron Isomaltoside injection |
| Placebo group | Placebo comparator | At the same time point, the same dose of physiological saline was infused. Receives: Drug: Physiological saline solution (as placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Hb concentration compared to baseline
Measured: 3 months post-surgery,
Secondary outcomes (3)
Incidence of anemia
Measured: 3 months, 6 months and 12 months after surgery
Iron metabolism indicators (serum ferritin, serum iron, total iron binding capacity, transferrin saturation)
Measured: 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%).
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Mar 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Meng, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236788
- Sponsor's protocol ID
- 2024-HX-133
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency.
- ClinicalTrials.gov ID
- NCT07236788
- Acronym / sponsor ID
- 2024-HX-133
- Conditions
- Obesity, Anemia, Iron Deficiencies, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Iron Isomaltoside injection3±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. |
| Placebo group | Placebo comparator | Drug: Physiological saline solution (as placebo)At the same time point, the same dose of physiological saline was infused. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron Isomaltoside injectionPatients 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 | Treatment group |
| Physiological saline solution (as placebo)At the same time point, the same dose of physiological saline was infused as the experimental group. | Drug | Placebo group |
Primary outcome
changes in Hb concentration compared to baseline
Time frame: 3 months post-surgery,
3 secondary outcomes
Incidence of anemia
Time frame: 3 months, 6 months and 12 months after surgery
Iron metabolism indicators (serum ferritin, serum iron, total iron binding capacity, transferrin saturation)
Time frame: 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%).
Time frame: 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron Isomaltoside injection in people with Obesity and Anemia, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nianrong Zhang Zhang (+86 188 1048 8650, znrsd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in Hb concentration compared to baseline (time frame: 3 months post-surgery,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.