Clinical trial

Iron Supplementation and Anemia After Sleeve Gastrectomy

Recruiting now · Not applicable · 1 countries · Registry ID NCT07397572

Recruiting nowNot applicableObservational

What this study is about

The goal of this observational study is to learn if taking extra iron pills after weight loss surgery helps prevent low iron and anemia compared to just taking a standard multivitamin. The main question it aims to answer is: Does a specific iron supplementation plan lower the number of patients who develop iron deficiency anemia in the 6 months after sleeve gastrectomy surgery? Researchers will compare two groups of patients from different hospital units to see if the extra iron works: Patients from one unit who take a prophylactic iron supplement (Ferrodep, 60 mg per day) in addition to their standard multivitamin. Patients from another unit who take only a standard multivitamin (Centrum Silver). Participants in this study will: * Have their blood tested for iron and anemia levels before surgery, and again at 3 and 6 months after surgery, as part of their regular post-operative care. * Be asked about their health and quality of life during follow-up clinic visits. * Have their medical information from their hospital records reviewed by the study team to track their progress.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionIron Deficiency Anemia, Obesity, Sleeve Gastrectomy

Full registry criteria

Inclusion Criteria: * Adults aged 18 to 65 years scheduled to undergo primary laparoscopic sleeve gastrectomy (LSG). * Capable of understanding and providing written informed consent for participation. * Able and willing to commit to the 6-month post-operative follow-up schedule at the bariatric clinic. Exclusion Criteria: * Prior history of major gastrointestinal surgery (e.g., bowel resection, gastrectomy) that could independently affect iron absorption. * Pre-existing malabsorptive conditions (e.g., inflammatory bowel disease, celiac disease). * Diagnosis of other known forms of anemia (e.g., thalassemia, vitamin B12/folate deficiency, anemia of chronic disease) that would confound the diagnosis of iron deficiency anemia (IDA). * Any condition that, in the investigator's judgment, would interfere with full participation in the study or pose a significant risk.

Treatments and study arms

Elemental Iron

Drug

Prophylactic oral iron supplement (Ferrodep®), prescribed as part of the standard post-operative care protocol at the participating unit. Each capsule contains 30 mg of elemental iron. The regimen is one capsule every 12 hours, for a total daily dose of 60 mg elemental iron, taken in addition to a daily multivitamin.

Multivitamin with Minerals

Dietary Supplement

A standard daily multivitamin with minerals (Centrum Silver®), prescribed as part of the routine post-operative care. This formulation contains approximately 10 mg of elemental iron. For participants in this unit's protocol, no additional prophylactic iron is routinely prescribed.

Primary outcomes

Incidence of Iron Deficiency Anemia (IDA) at 6 Months6 Months Post-Surgery

Proportion of participants diagnosed with IDA. Diagnosis requires: 1) Anemia (Hemoglobin \<13 g/dL in males or \<12 g/dL in females), AND 2) Iron Deficiency, defined by at least one of: serum ferritin \<30 ng/mL, TIBC \>450 µg/dL, or serum iron \<75 µg/dL (male)/\<60 µg/dL (female).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Faculty of Medicine Cairo University🇪🇬 Cairo, Al-Manial Cairo, Egypt

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