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Recruiting NCT07366502

Liposomal vs Conventional Oral Iron After Sleeve Gastrectomy

No phase Interventional İron Deficiency Anemia Liposomal Iron Replacement Conventional Iron Replacement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liposomal Iron, conventional oral iron.
Who it may be relevant to
Registry conditions: İron Deficiency Anemia, Liposomal Iron Replacement, Conventional Iron Replacement. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Drug Liposomal Iron
    Oral liposomal iron capsules containing 17 iron per capsule, adminstered as 2 capsules daily, taken independently of meals for 3 months.
  • 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.

Primary outcome measures

  • Change in Hemoglobin Level From Baseline to Week 24 [Time frame: 24 weeks]
Secondary outcome measures (3)
  • Change in Serum Ferritin Level From Baseline to Week 24 [Time frame: 24 weeks]
  • Change in Transferrin Saturation (TSAT) From Baseline to Week 24 [Time frame: 24 weeks]
  • Change in Serum Iron Level From Baseline to Week 24 [Time frame: 24 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Goztepe Prof.Dr. Suleyyman Yalçın City Hospital — Istanbul

Identifiers

NCT: NCT07366502 · 2025-GOSEK-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗