Iron Supplementation and Anemia After Sleeve Gastrectomy

NCT07397572 | Recruiting

• 1 other identifier: MS-679-2025
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency Anemia; Obesity; Sleeve Gastrectomy

Keywords

Laparoscopic Sleeve Gastrectomy; Bariatric Surgery; Iron Deficiency Anemia; Iron Supplementation; Multivitamin; Morbid Obesity; Observational Study

Outcome Measures

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).

  6 Months Post-Surgery

Secondary Outcomes (8)

• Change in Hemoglobin Concentration

  Baseline, 3 Months, 6 Months

• Change in Serum Ferritin Level

  Baseline, 3 Months, 6 Months

• Change in Transferrin Saturation (TSAT)

  Baseline, 3 Months, 6 Months

• Incidence of Isolated Iron Deficiency without anemia

  3 Months, 6 Months

• Rate of Oral Iron Intolerance

  6 Months Post-Surgery

Study Arms (2)

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; Dietary Supplement: Multivitamin with Minerals

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

Interventions

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.

Prophylactic Oral Iron Group

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.

Prophylactic Oral Iron Group; Standard Multivitamin Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, Al-Manial Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Obesity; Obesity, Morbid

Interventions

Geritol; Minerals

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Aziz

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Eid Aziz, Lecturer

CONTACT

+201127060844; Ahmed-eid@kasralainy.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: January 17, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)