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NCT Number: NCT07366502

Liposomal vs Conventional Oral Iron After Sleeve Gastrectomy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goztepe Prof.Dr. Suleyyman Yalçın City Hospital

Istanbul, kadıköy, 34630, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gürhan Baş, Prof.

CONTACT

[email protected]

+902166065200

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal iron

Drug

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

conventional oral iron

Drug

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 outcomes

  1. Change in Hemoglobin Level From Baseline to Week 24

    Time frame: 24 weeks

    The change in hemoglobin concentration will be calculated as the absolute difference between baseline and week 24 values.

Secondary outcomes

  1. Change in Serum Ferritin Level From Baseline to Week 24

    Time frame: 24 weeks

    Absolute change in serum ferritin concentration from baseline to week 24.

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

    Time frame: 24 weeks

    Absolute change in transferrin saturation percentage from baseline to week 24.

  3. Change in Serum Iron Level From Baseline to Week 24

    Time frame: 24 weeks

    Absolute change in serum iron concentration from baseline to week 24.

Study contacts

Contact information is provided by the study sponsor or research team.

Medeni Sermet, assoc.prof

CONTACT

[email protected]

+905072367020

Sponsors and collaborators

Lead sponsor

Medeni Şermet

Other

Registry information

Official study 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

Acronym: anemia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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