Iron Supplementation and Anemia After Sleeve Gastrectomy
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: Elemental Iron, Multivitamin with Minerals.
- Who it may be relevant to
- Registry conditions: Iron Deficiency Anemia, Obesity, Sleeve Gastrectomy. 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
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prophylactic Oral Iron Supplementation for the Prevention of Iron Deficiency Anemia After Sleeve Gastrectomy: A Prospective Comparative Cohort Study
Overview
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.
Detailed description
Background and Rationale Iron deficiency anemia (IDA) is a prevalent and clinically significant long-term complication following Laparoscopic Sleeve Gastrectomy (LSG), the most commonly performed bariatric procedure worldwide. Despite universal multivitamin supplementation, the incidence of IDA rises steadily post-operatively, impacting patient quality of life, cognitive function, and healthcare utilization. A critical evidence gap exists regarding the efficacy of routine prophylactic oral iron supplementation compared to a strategy of standard multivitamin use with iron monitoring. Current guidelines lack consensus due to insufficient comparative long-term data. This study aims to provide high-level evidence to inform postoperative protocols by directly comparing these two distinct management strategies.
Study Design and Setting This is a prospective, observational, comparative cohort study conducted within the bariatric surgery units of Kasr Al-Ainy Hospital, Cairo University. The study leverages existing, routine clinical practices at two participating units, allowing for a real-world comparison of outcomes. Participants will be managed according to the standard post-operative supplementation protocol of their treating surgical unit; the research protocol does not assign interventions.
Study Cohorts
Eligible participants will be enrolled into one of two cohorts based on the standard care protocol of their surgical unit:
Prophylactic Iron Cohort: Patients whose standard care includes a daily prophylactic dose of 60 mg elemental iron (administered as Ferrodep®, 30 mg capsule every 12 hours) in addition to a daily standard multivitamin.
Standard Multivitamin Cohort: Patients whose standard care includes a daily standard multivitamin only (e.g., Centrum Silver®), which contains approximately 10 mg of iron, with no additional prophylactic iron.
Study Procedures and Assessments Consecutively enrolled patients scheduled for primary LSG will be assessed pre-operatively (baseline) and at 3 and 6 months post-operatively. Data collection will include standardized laboratory panels (hemoglobin, ferritin, iron studies, complete blood count indices), documentation of supplementation adherence, and patient-reported outcome measures. All primary and secondary outcome measures are pre-specified and listed in the designated module.
Statistical Considerations The primary outcome is the cumulative incidence of IDA at 6 months post-surgery, with IDA defined per protocol-specific laboratory criteria. Secondary outcomes include longitudinal changes in hematological parameters, adherence rates, and patient-reported fatigue. A sample size of 66 participants (33 per cohort) was calculated to provide 85% power to detect a significant difference in the primary outcome. Data will be analyzed using SPSS software with appropriate statistical tests for between-group comparisons, as detailed in the statistical analysis plan.
Interventions
- Drug Elemental Iron
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. - Dietary supplement Multivitamin with Minerals
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 outcome measures
- Incidence of Iron Deficiency Anemia (IDA) at 6 Months [Time frame: 6 Months Post-Surgery]
Secondary outcome measures (8)
- Change in Hemoglobin Concentration [Time frame: Baseline, 3 Months, 6 Months]
- Change in Serum Ferritin Level [Time frame: Baseline, 3 Months, 6 Months]
- Change in Transferrin Saturation (TSAT) [Time frame: Baseline, 3 Months, 6 Months]
- Incidence of Isolated Iron Deficiency without anemia [Time frame: 3 Months, 6 Months]
- Rate of Oral Iron Intolerance [Time frame: 6 Months Post-Surgery]
- Adherence to Oral Supplementation [Time frame: 3 Months, 6 Months]
- Fatigue Severity Score] [Time frame: Baseline, 3 Months, 6 Months]
- Need for Therapeutic Iron Supplementation [Time frame: 6 Months Post-Surgery]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Faculty of Medicine Cairo University — Cairo
Identifiers
NCT: NCT07397572 · MS-679-2025