Liposomal vs Conventional Oral Iron After Sleeve Gastrectomy (anemia)

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.

Study Overview

• Status: Recruiting
• Conditions: İron Deficiency Anemia; Liposomal Iron Replacement; Conventional Iron Replacement
• Intervention / Treatment: Drug: Liposomal Iron; Drug: conventional oral iron

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Medeni Sermet, assoc.prof; Phone Number: +905072367020; Email: sermetmedeni@gmail.com

Study Locations

• Turkey (Türkiye)
  • kadıköy
    • Istanbul, kadıköy, Turkey (Türkiye), 34630
      • Recruiting
      • Goztepe Prof.Dr. Suleyyman Yalçın City Hospital
      • Contact: Gürhan Baş, Prof.; Phone Number: +902166065200; Email: medeniyetuniversity@medeniyet.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 Title: Liposomal Iron (Group LD); Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving oral liposomal iron.	Drug: Liposomal Iron; Oral liposomal iron capsules containing 17 iron per capsule, adminstered as 2 capsules daily, taken independently of meals for 3 months.; Other Names: nano encapsule bioferrP
Active Comparator: Arm 2 Title: Conventional Iron (Group KD); Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving conventional oral ferrous iron preparations.	Drug: conventional oral iron; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Ferritin Level From Baseline to Week 24	Absolute change in serum ferritin concentration from baseline to week 24.	24 weeks
Change in Transferrin Saturation (TSAT) From Baseline to Week 24	Absolute change in transferrin saturation percentage from baseline to week 24.	24 weeks
Change in Serum Iron Level From Baseline to Week 24	Absolute change in serum iron concentration from baseline to week 24.	24 weeks

Collaborators and Investigators

• Sponsor: Medeni Şermet

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): July 25, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Iron deficiency anemia; Complications; Laparoscopic Sleeve Gastrectomy; Post-Bariatric surgery; Liposomal ıron; Conventional ıron
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Anemia, Iron-Deficiency
• Other Study ID Numbers: 2025-GOSEK-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We can share anonymized demographic and laboratory data upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No