Iron Supplementation and Anemia After Sleeve Gastrectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult patients with morbid obesity scheduled to undergo primary laparoscopic sleeve gastrectomy (LSG) at the participating bariatric surgery units.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Elemental Iron
DrugProphylactic 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 supplementA 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Prophylactic Oral Iron Group2 interventions
Group B: Standard Multivitamin Group1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Iron Deficiency Anemia (IDA) at 6 Months
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).
Time frame
6 Months Post-SurgerySecondary outcomes
1
Change in Hemoglobin Concentration
Mean change in hemoglobin concentration (g/dL) from baseline to follow-up.
Time frame
Baseline, 3 Months, 6 Months2
Change in Serum Ferritin Level
Mean change in serum ferritin concentration (ng/mL) from baseline to follow-up.
Time frame
Baseline, 3 Months, 6 Months3
Change in Transferrin Saturation (TSAT)
Mean change in Transferrin Saturation percentage, calculated from serum iron and TIBC.
Time frame
Baseline, 3 Months, 6 Months4
Incidence of Isolated Iron Deficiency without anemia
Proportion of participants with serum ferritin \<30 ng/mL and normal hemoglobin (≥12 g/dL female, ≥13 g/dL male).
Time frame
3 Months, 6 MonthsSponsors and contacts
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Source ClinicalTrials.gov