İron Deficiency AnemiaanemiaNCT07366502
Liposomal vs Conventional Oral Iron After Sleeve Gastrectomy
A study testing Liposomal Iron and conventional oral iron in people with İron Deficiency Anemia and Liposomal Iron Replacement, run by Medeni Şermet at 1 site in Turkey (Türkiye).
Trial summary
Low-dose liposomal iron (17-34 mg elemental/day) was compared with standard conventional oral iron (100-200mg elemental/day) in the treatment of iron deficiency anemia following sleeve gastrectomy. Liposomal iron provided superior hematological improvement and gastrointestinal tolerance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- İron Deficiency Anemia, Liposomal Iron Replacement, Conventional Iron Replacement
- What is being tested?
- Liposomal Iron and conventional oral iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age between 18 and 65 years
- History of laparoscopic sleeve gastrectomy performed at least 6 months prior to enrollment
- Diagnosis of iron deficiency anemia, defined as:
- Hemoglobin <12 g/dL in women or <13 g/dL in men, and
- Serum ferritin <30 ng/mL or transferrin saturation (TSAT) <20%
- Mild to moderate anemia (hemoglobin ≥9 g/dL)
Show all 18Show fewer
- Ability to take and swallow oral medications
- Willingness to participate and provide written informed consent Exclusion Criteria
- Active gastrointestinal disease (e.g., inflammatory bowel disease, peptic ulcer disease, or gastrointestinal bleeding)
- Chronic kidney disease with estimated GFR <30 mL/min/1.73 m²
- Use of oral or parenteral iron, vitamin B12, or folate supplementation within the previous 3 months
- Iron overload or hemochromatosis (serum ferritin >300 ng/mL)
- Known allergy or intolerance to iron preparations
- Active malignancy
- Pregnancy or breastfeeding
- Known hemoglobinopathies (e.g., thalassemia, sickle cell disease)
- Blood transfusion within the previous 1 month
- Cognitive or psychiatric disorder interfering with study participation or protocol adherence
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Goztepe Prof.Dr. Suleyyman Yalçın City Hospital
Istanbul, kadıköy, 34630
About this study
Official title: Comprehensive Hematological and Biochemical Comparison of Low-Dose Liposomal Iron Versus Standard-Dose Conventional Oral Iron in Iron Deficiency Anemia Following Sleeve Gastrectomy: A Prospective, Randomized Clinical Trial
Low-dose liposomal iron (17-34 mg elemental/day) was compared with standard conventional oral iron (100-200mg elemental/day) in the treatment of iron deficiency anemia following sleeve gastrectomy. Liposomal iron provided superior hematological improvement and gastrointestinal tolerance.
- Being tested
- Liposomal Iron, conventional oral iron
- Keywords
- Iron deficiency anemia, Post-Bariatric surgery, Complications, Laparoscopic Sleeve Gastrectomy, Liposomal ıron, Conventional ıron
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal IronDrug
Also called nano encapsule bioferrP
Oral liposomal iron capsules containing 17 iron per capsule, adminstered as 2 capsules daily, taken independently of meals for 3 months.
conventional oral ironDrug
oral ferrous iron preparations (ferrous sulfate), each providing 160 mg elemental iron once daily, administered on an empty stomatch with 200 mg vitamin c for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Title: Liposomal Iron (Group LD) | Experimental | Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving oral liposomal iron. Receives: Drug: Liposomal Iron |
| Arm 2 Title: Conventional Iron (Group KD) | Active comparator | Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving conventional oral ferrous iron preparations. Receives: Drug: conventional oral iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin Level From Baseline to Week 24
The change in hemoglobin concentration will be calculated as the absolute difference between baseline and week 24 values.
Measured: 24 weeks
Secondary outcomes (3)
Change in Serum Ferritin Level From Baseline to Week 24
Absolute change in serum ferritin concentration from baseline to week 24.
Measured: 24 weeks
Change in Transferrin Saturation (TSAT) From Baseline to Week 24
Absolute change in transferrin saturation percentage from baseline to week 24.
Measured: 24 weeks
Change in Serum Iron Level From Baseline to Week 24
Absolute change in serum iron concentration from baseline to week 24.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Sep 2025
- Primary completion25 May 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for İron Deficiency AnemiaStudies of the same condition, open and under way.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medeni Şermet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Medeni Şermet, Goztepe Prof Dr Suleyman Yalcın City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366502
- Sponsor's protocol ID
- 2025-GOSEK-102
- Acronym
- anemia
- Status last verified
- Nov 2026
- First submitted
- 24 Dec 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share anonymized demographic and laboratory data upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Hematological and Biochemical Comparison of Low-Dose Liposomal Iron Versus Standard-Dose Conventional Oral Iron in Iron Deficiency Anemia Following Sleeve Gastrectomy: A Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07366502
- Acronym / sponsor ID
- anemia / 2025-GOSEK-102
- Keywords
- Iron deficiency anemia, Post-Bariatric surgery, Complications, Laparoscopic Sleeve Gastrectomy, Liposomal ıron, Conventional ıron
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medeni ŞermetUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 26 Jan 2026 (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.
Low-dose liposomal iron (17-34 mg elemental/day) was compared with standard conventional oral iron (100-200mg elemental/day) in the treatment of iron deficiency anemia following sleeve gastrectomy. Liposomal iron provided superior hematological improvement and gastrointestinal tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Title: Liposomal Iron (Group LD) | Experimental | Drug: Liposomal IronParticipants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving oral liposomal iron. |
| Arm 2 Title: Conventional Iron (Group KD) | Active comparator | Drug: conventional oral ironParticipants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving conventional oral ferrous iron preparations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age between 18 and 65 years
- History of laparoscopic sleeve gastrectomy performed at least 6 months prior to enrollment
- Diagnosis of iron deficiency anemia, defined as:
- Hemoglobin <12 g/dL in women or <13 g/dL in men, and
- Serum ferritin <30 ng/mL or transferrin saturation (TSAT) <20%
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Liposomal IronAlso: nano encapsule bioferrPOral liposomal iron capsules containing 17 iron per capsule, adminstered as 2 capsules daily, taken independently of meals for 3 months. | Drug | Arm 1 Title: Liposomal Iron (Group LD) |
| conventional oral ironoral ferrous iron preparations (ferrous sulfate), each providing 160 mg elemental iron once daily, administered on an empty stomatch with 200 mg vitamin c for 3 months. | Drug | Arm 2 Title: Conventional Iron (Group KD) |
Primary outcome
Change in Hemoglobin Level From Baseline to Week 24
Time frame: 24 weeks
The change in hemoglobin concentration will be calculated as the absolute difference between baseline and week 24 values.
3 secondary outcomes
Change in Serum Ferritin Level From Baseline to Week 24
Time frame: 24 weeks
Change in Transferrin Saturation (TSAT) From Baseline to Week 24
Time frame: 24 weeks
Change in Serum Iron Level From Baseline to Week 24
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We can share anonymized demographic and laboratory data upon request.
Related trials for İron Deficiency Anemia
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal Iron and conventional oral iron in people with İron Deficiency Anemia and Liposomal Iron Replacement, run by Medeni Şermet at 1 site in Turkey (Türkiye).
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 18 inclusion and 0 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: finished, as of the sponsor's last update on 3 Nov 2026. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin Level From Baseline to Week 24 (time frame: 24 weeks). 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 3 Nov 2026.