Liposomal vs Conventional Oral Iron After Sleeve Gastrectomy

NCT07366502 | Recruiting DMC

• 1 other identifier: 2025-GOSEK-102
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

İron Deficiency Anemia; Liposomal Iron Replacement; Conventional Iron Replacement

Keywords

Iron deficiency anemia; Post-Bariatric surgery; Complications; Laparoscopic Sleeve Gastrectomy; Liposomal ıron; Conventional ıron

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Serum Ferritin Level From Baseline to Week 24

  24 weeks

• Change in Transferrin Saturation (TSAT) From Baseline to Week 24

  24 weeks

• Change in Serum Iron Level From Baseline to Week 24

  24 weeks

Study Arms (2)

Arm 1 Title: Liposomal Iron (Group LD)

EXPERIMENTAL

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

Drug: Liposomal Iron

Arm 2 Title: Conventional Iron (Group KD)

ACTIVE COMPARATOR

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

Drug: conventional oral iron

Interventions

Liposomal Iron DRUG

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

Arm 1 Title: Liposomal Iron (Group LD)

conventional oral iron DRUG

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

Arm 2 Title: Conventional Iron (Group KD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medeni Şermet: lead

Study Sites (1)

Goztepe Prof.Dr. Suleyyman Yalçın City Hospital

Istanbul, kadıköy, 34630, Turkey (Türkiye)

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Medeni Sermet, assoc.prof

CONTACT

+905072367020; sermetmedeni@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assoc.prof., MD.

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 26, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)