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RecruitingNot ApplicableNCT07366502

Liposomal vs Conventional 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

Sponsor

Medeni Şermet

Enrollment

70 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

İron Deficiency AnemiaLiposomal Iron ReplacementConventional Iron Replacement

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

  • 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

Exclusion Criteria10

  • 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
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Interventions

DRUGLiposomal Iron

Oral liposomal iron capsules containing 17 iron per capsule, adminstered as 2 capsules daily, taken independently of meals for 6 months.

DRUGconventional oral iron

oral ferrous iron preparations (ferrous sulfate, ferrous fumarate, or ferrous gluconate), each providing 100-200 mg elemental iron once daily, administered on an empty stomatch with 200 mg vitamin c for 6 months.

Locations(1)

Goztepe Prof.Dr. Suleyyman Yalçın City Hospital

Istanbul, kadıköy, Turkey (Türkiye)

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NCT07366502