Conventional Iron Replacement, İron Deficiency Anemia, Liposomal Iron Replacement
Conditions
Keywords
Iron deficiency anemia, Post-Bariatric surgery, Complications, Laparoscopic Sleeve Gastrectomy, Liposomal ıron, Conventional ıron
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.
Interventions
DRUGLiposomal Iron
Oral liposomal iron capsules containing 17 iron per capsule, adminstered as 2 capsules daily, taken independently of meals for 3 months.
DRUGconventional 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.
Sponsors
Medeni Şermet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin Level From Baseline to Week 24 | 24 weeks | The change in hemoglobin concentration will be calculated as the absolute difference between baseline and week 24 values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Ferritin Level From Baseline to Week 24 | 24 weeks | Absolute change in serum ferritin concentration from baseline to week 24. |
| Change in Transferrin Saturation (TSAT) From Baseline to Week 24 | 24 weeks | Absolute change in transferrin saturation percentage from baseline to week 24. |
| Change in Serum Iron Level From Baseline to Week 24 | 24 weeks | Absolute change in serum iron concentration from baseline to week 24. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMedeni Sermet, assoc.prof
Outcome results
None listed