Liposomal vs Conventional Oral Iron After Sleeve Gastrectomy (anemia)

Medeni Şermet

Status: Enrolling

Conditions: Conventional Iron Replacement; İron Deficiency Anemia; Liposomal Iron Replacement

Treatments: Drug: Liposomal Iron; Drug: conventional oral iron

Study type: Interventional

Funder types: Other

Identifiers

NCT07366502

2025-GOSEK-102

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Arm 1 Title: Liposomal Iron (Group LD)

Experimental group

Description:

Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving oral liposomal iron.

Treatment:

Drug: Liposomal Iron

Arm 2 Title: Conventional Iron (Group KD)

Active Comparator group

Description:

Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving conventional oral ferrous iron preparations.

Treatment:

Drug: conventional oral iron