Iron Deficiency AnemiaNCT07397572
Iron Supplementation and Anemia After Sleeve Gastrectomy
An observational study of Iron Deficiency Anemia and Obesity, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Iron Deficiency Anemia, Obesity, Sleeve Gastrectomy
- What is being tested?
- Elemental Iron and Multivitamin with Minerals
- Type of treatment
- Pill or oral medicine
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2026to Jan 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with morbid obesity scheduled to undergo primary laparoscopic sleeve gastrectomy (LSG) at the participating bariatric surgery units.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Cairo University
Cairo, Al-Manial Cairo
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Iron Deficiency Anemia, Obesity, Sleeve Gastrectomy
- Being tested
- Elemental Iron, Multivitamin with Minerals
- Keywords
- Laparoscopic Sleeve Gastrectomy, Bariatric Surgery, Iron Deficiency Anemia, Iron Supplementation, Multivitamin, Morbid Obesity, Observational Study
- Medical subject headings
- Anemia, Iron-Deficiency, Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elemental IronDrug
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 MineralsDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Multivitamin with Minerals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 Months Post-Surgery
Secondary outcomes (8)
Change in Hemoglobin Concentration
Mean change in hemoglobin concentration (g/dL) from baseline to follow-up.
Measured: Baseline, 3 Months, 6 Months
Change in Serum Ferritin Level
Mean change in serum ferritin concentration (ng/mL) from baseline to follow-up.
Measured: Baseline, 3 Months, 6 Months
Change in Transferrin Saturation (TSAT)
Mean change in Transferrin Saturation percentage, calculated from serum iron and TIBC.
Measured: 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).
Measured: 3 Months, 6 Months
Rate of Oral Iron Intolerance
Proportion experiencing gastrointestinal effects leading to dose reduction, interruption, or discontinuation of iron.
Measured: 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.
Measured: 3 Months, 6 Months
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.
Measured: Baseline, 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.
Measured: 6 Months Post-Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start17 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Eid Ali Ahmed Aziz, Cairo University
- Investigators
- Aziz, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397572
- Sponsor's protocol ID
- MS-679-2025
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Oral Iron Supplementation for the Prevention of Iron Deficiency Anemia After Sleeve Gastrectomy: A Prospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT07397572
- Acronym / sponsor ID
- MS-679-2025
- Conditions
- Iron Deficiency Anemia, Obesity, Sleeve Gastrectomy
- Keywords
- Laparoscopic Sleeve Gastrectomy, Bariatric Surgery, Iron Deficiency Anemia, Iron Supplementation, Multivitamin, Morbid Obesity, Observational Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Oral Iron Group | – | Drug: Elemental Iron, Dietary Supplement: Multivitamin with MineralsPatients 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. |
| Standard Multivitamin Group | – | Dietary Supplement: Multivitamin with MineralsPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with morbid obesity scheduled to undergo primary laparoscopic sleeve gastrectomy (LSG) at the participating bariatric surgery units.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elemental IronProphylactic 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. | Drug | Prophylactic Oral Iron Group |
| Multivitamin with MineralsA 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. | Dietary supplement | Prophylactic Oral Iron Group, Standard Multivitamin Group |
Primary outcome
Incidence of Iron Deficiency Anemia (IDA) at 6 Months
Time frame: 6 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).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aziz principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia and Obesity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Eid Aziz, Lecturer (+201127060844, Ahmed-eid@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Iron Deficiency Anemia (IDA) at 6 Months (time frame: 6 Months Post-Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.