Liposomal versus standard oral iron after sleeve gastrectomy

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

This will test whether low-dose liposomal iron helps people with iron deficiency after sleeve gastrectomy more effectively and with fewer stomach side effects than standard oral iron.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital (Academic / other)
• Locations: 1 site (Istanbul, kadıköy)
• Trial ID: NCT07366502 on ClinicalTrials.gov

What this trial studies

Adults who had laparoscopic sleeve gastrectomy at least six months earlier and have mild-to-moderate iron deficiency anemia received either low-dose liposomal iron (17–34 mg elemental/day) or conventional oral iron (100–200 mg elemental/day). Hemoglobin, ferritin, transferrin saturation, and other blood counts were measured over the treatment period to compare hematologic response. Gastrointestinal side effects and tolerability were recorded to compare patient comfort and adherence between the two formulations. The single-center trial excluded patients with active GI disease, severe kidney disease, recent iron therapy, pregnancy or breastfeeding, iron overload, or known hemoglobinopathies.

Who should consider this trial

Good fit: Adults 18–65 years who underwent sleeve gastrectomy at least six months earlier and have mild-to-moderate iron deficiency anemia (hemoglobin ≥9 g/dL and ferritin <30 ng/mL or TSAT <20%) are the intended candidates.

Not a fit: Patients with active GI disease, severe renal impairment (eGFR <30 mL/min/1.73 m²), recent iron or B12/folate supplementation, iron overload, pregnancy or breastfeeding, active malignancy, or known hemoglobinopathies are unlikely to be eligible or to benefit from the oral regimens tested.

Why it matters

Potential benefit: If successful, low-dose liposomal iron could correct anemia with fewer gastrointestinal side effects and a lower pill burden than standard high-dose oral iron.

How similar studies have performed: Prior small studies and observational reports have suggested liposomal iron can improve absorption and cause fewer GI side effects than conventional oral iron, but larger confirmatory trials are limited.

Eligibility criteria

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

Where this trial is running

Istanbul, kadıköy

• Goztepe Prof.Dr. Suleyyman Yalçın City Hospital — Istanbul, kadıköy, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Medeni Sermet, assoc.prof

Conditions İron Deficiency Anemia; Liposomal Iron Replacement; Conventional Iron Replacement; Iron deficiency anemia; Post-Bariatric surgery; Complications; Laparoscopic Sleeve Gastrectomy; Liposomal ıron