Liposomal vs Conventional Oral Iron After Sleeve Gastrectomy

NCT07366502 — Not applicable, Recruiting, 70 participants, Medeni Şermet

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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

Registry	NCT07366502, acronym anemia
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	70 (Estimated)
Sponsor	Medeni Şermet (Other)
Conditions	İron Deficiency Anemia, Liposomal Iron Replacement, Conventional Iron Replacement
Interventions	Liposomal Iron, conventional oral iron (Drug)
Dates	start 2025-09-01, primary completion 2026-07-25 (estimated), completion 2026-07-30 (estimated), first posted 2026-01-26, last updated 2026-07-13
Locations	1 site in Turkey (Türkiye)

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Arm 1 Title: Liposomal Iron (Group LD)	Experimental	Drug: Liposomal Iron	Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving oral liposomal iron.
Arm 2 Title: Conventional Iron (Group KD)	Active comparator	Drug: conventional oral iron	Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving conventional oral ferrous iron preparations.

Liposomal Iron (Drug), also known as 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 iron (Drug): 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.

+Outcome measures

Primary outcomes

Change in Hemoglobin Level From Baseline to Week 24 [24 weeks]: The change in hemoglobin concentration will be calculated as the absolute difference between baseline and week 24 values.

Secondary outcomes

Change in Serum Ferritin Level From Baseline to Week 24 [24 weeks]: Absolute change in serum ferritin concentration from baseline to week 24.
Change in Transferrin Saturation (TSAT) From Baseline to Week 24 [24 weeks]: Absolute change in transferrin saturation percentage from baseline to week 24.
Change in Serum Iron Level From Baseline to Week 24 [24 weeks]: Absolute change in serum iron concentration from baseline to week 24.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria

* 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)
* 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

+Locations (1)

Facility	City	Country	Status
Goztepe Prof.Dr. Suleyyman Yalçın City Hospital	Istanbul, kadıköy	Turkey (Türkiye)	Recruiting

+Study documents

Study Protocol (PDF, 2025-01-24)

My Notes

Public

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