Iron Supplementation and Anemia After Sleeve Gastrectomy

Prophylactic Oral Iron Supplementation for the Prevention of Iron Deficiency Anemia After Sleeve Gastrectomy: A Prospective Comparative Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Iron Deficiency Anemia; Sleeve Gastrectomy
• Intervention / Treatment: Drug: Elemental Iron; Dietary supplement: Multivitamin with Minerals

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.

• Study Type: Observational
• Enrollment (Estimated): 66

Contacts and Locations

• Study Contact: Name: Ahmed Eid Aziz, Lecturer; Phone Number: +201127060844; Email: Ahmed-eid@kasralainy.edu.eg

Study Locations

• Egypt
  • Al-Manial Cairo
    • Cairo, Al-Manial Cairo, Egypt
      • Recruiting
      • Faculty of medicine Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with morbid obesity scheduled to undergo primary laparoscopic sleeve gastrectomy (LSG) at the participating bariatric surgery units.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prophylactic Oral Iron Group; Patients from the bariatric surgery unit whose standard postoperative care includes a prophylactic oral iron regimen. This consists of Ferrodep® (30 mg elemental iron per capsule), one capsule every 12 hours (total 60 mg/day), in addition to a daily standard multivitamin.	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.
Standard Multivitamin Group; Patients from the bariatric surgery unit whose standard postoperative care includes a daily standard multivitamin only (e.g., Centrum Silver®), which contains approximately 10 mg of iron. No additional prophylactic iron is routinely prescribed.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 Months Post-Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin Concentration	Mean change in hemoglobin concentration (g/dL) from baseline to follow-up.	Baseline, 3 Months, 6 Months
Change in Serum Ferritin Level	Mean change in serum ferritin concentration (ng/mL) from baseline to follow-up.	Baseline, 3 Months, 6 Months
Change in Transferrin Saturation (TSAT)	Mean change in Transferrin Saturation percentage, calculated from serum iron and TIBC.	Baseline, 3 Months, 6 Months
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).	3 Months, 6 Months
Rate of Oral Iron Intolerance	Proportion experiencing gastrointestinal effects leading to dose reduction, interruption, or discontinuation of iron.	6 Months Post-Surgery
Adherence to Oral Supplementation	Adherence expressed as the percentage of prescribed doses taken, calculated from pill count at follow-up clinic visits.	3 Months, 6 Months
Need for Therapeutic Iron Supplementation	Proportion of participants who require initiation of new therapeutic iron during follow-up per clinician judgment.	6 Months Post-Surgery
Fatigue Severity Score]	Mean score on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale.The FACIT-Fatigue scale consists of 13 items, with total scores ranging from 0 to 52, where higher scores indicate less fatigue and better quality of life.	Baseline, 3 Months, 6 Months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Aziz, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Morbid Obesity; Observational Study; Bariatric Surgery; Iron Deficiency Anemia; Laparoscopic Sleeve Gastrectomy; Multivitamin; Iron Supplementation
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Hematologic Diseases; Overweight; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Hemic and Lymphatic Diseases; Iron Deficiencies; Obesity; Anemia, Iron-Deficiency; Obesity, Morbid; Inorganic Chemicals; Geritol; Minerals
• Other Study ID Numbers: MS-679-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No