Vitamin DeficienciesPhase 4NCT07021170
Trial Comparing Elan Specialized Bariatric Supplements With Standard Multivitamins in Patients Undergoing Bariatric Procedures
A Phase 4 study testing Elan Believe, Elan Compass and Elan Supreme in people with Vitamin Deficiencies, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial summary
Obesity has escalated to pandemic levels, impacting over 650 million adults globally and significantly contributing to the burden of non-communicable diseases such as type 2 diabetes, cardiovascular disease, obstructive sleep apnea, non-alcoholic fatty liver disease, and infertility. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin Deficiencies
- What is being tested?
- Elan Believe, Elan Compass and Elan Supreme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2025to 26 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible participants must be adults:
- Aged 18 to 65 years
- Capable of providing informed consent
- Willing to comply with study procedures and follow-up visits over 12 months.
- Candidates must have no prior history of MBS or gastrointestinal surgery and must be scheduled for one of the three aforementioned primary procedures.
- Both male and female patients will be considered, and no restrictions will be placed based on ethnicity or socioeconomic status.
Who cannot join
- The presence of chronic conditions that may independently affect micronutrient metabolism or absorption, such as chronic kidney disease, inflammatory bowel disease, or hepatic insufficiency.
- Additional exclusion criteria include pregnancy or lactation at the time of enrollment
- Plans for pregnancy within the study period
- Active malignancy
- Any use of investigational drugs or supplements within the past 30 days.
- Patients undergoing revisional bariatric surgery or conversion procedures will also be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, Alexandria Governorate, 21531
About this study
Official title: A Double-Blinded Randomized Controlled Trial Comparing Elan Specialized Bariatric Supplements With Standard Multivitamins in Patients Undergoing Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, and One-Anastomosis Gastric Bypass
Obesity has escalated to pandemic levels, impacting over 650 million adults globally and significantly contributing to the burden of non-communicable diseases such as type 2 diabetes, cardiovascular disease, obstructive sleep apnea, non-alcoholic fatty liver disease, and infertility. The chronic, multifactorial nature of obesity presents substantial challenges for long-term management, as lifestyle modifications and pharmacotherapy often yield limited and transient success. In this context, Metabolic and bariatric surgery (MBS) has emerged as the most effective and enduring treatment for obesity, offering significant weight loss and marked improvement or remission of obesity-related comorbidities.
The most prevalent MBS procedures include sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one-anastomosis gastric bypass (OAGB). While these interventions offer considerable metabolic advantages, they inherently cause significant modifications to gastrointestinal anatomy and physiology, which can predispose patients to long-term micronutrient deficiencies. These deficiencies can stem from reduced dietary intake, altered gastric acid secretion, decreased intrinsic factor production, and the bypassing of critical absorptive sites in the gastrointestinal tract. Commonly affected nutrients encompass iron, vitamin B12, Vitamin B6, folate, vitamin D, calcium, and zinc. If not effectively managed, these nutrient deficiencies can lead to anemia, secondary hyperparathyroidism, osteopenia, neurological complications, immune dysfunction, and impaired postoperative recovery.
Read more
Population-based recommended dietary allowances (RDAs) and tolerable upper intake levels (ULs) tend to underestimate the nutritional requirements for postoperative patients, as they are derived from healthy cohorts. Many standard formulations may fall short due to inadequate dosages, non-bioavailable forms, or poor tolerability, which can significantly impact patient adherence to supplementation regimens. Over-the-counter multivitamins, such as Centrum®, are designed for the general population and often lack the dosing, bioavailability, or elemental forms required for post-MBS physiology, particularly following bypass procedures.
The American Society for Metabolic and Bariatric Surgery (ASMBS) recommends 8-22 mg of elemental zinc per day, depending on the procedure, and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) and the World Gastroenterology Organization (WGO) recommend up to 30 mg/day for OAGB patients. These values are below the national upper limit in Egypt, which is 25 mg/day.
Moreover, there is evidence indicating a discrepancy in nutrient deficiencies among different bariatric surgery patients; for instance, OAGB patients exhibit a greater prevalence of iron and zinc deficiencies compared to those undergoing RYGB or SG, thereby necessitating proportionally higher supplementation tailored to their specific needs.
Read the detailed description
Consequently, specialized supplements containing adjusted doses of iron, zinc, and copper, within or slightly exceeding international guideline recommendations, are proposed to address the heightened risk of deficiencies, particularly in MBS procedures such as RYGB and OAGB, which are both clinically necessary and scientifically supported. In response to these shortcomings, specialized MBS supplements have been formulated to meet the unique physiological requirements and anatomical changes associated with each surgical procedure. The Elan Bariatric Supplement line, featuring Elan Believe for sleeve gastrectomy, Elan Compass for Roux-en-Y gastric bypass, and Elan Supreme for omega-loop gastric bypass, illustrates this tailored approach. It combines procedure-specific formulations aimed at optimizing nutrient absorption, minimizing gastrointestinal side effects, and enhancing patient compliance.
Despite the theoretical benefits of these specialized formulations, robust evidence supporting their clinical superiority over standard multivitamins remains scarce. Randomized controlled trials are warranted to ascertain whether these tailored supplements lead to improved nutritional status, enhanced tolerability, and superior overall outcomes in the post-MBS population. The present study intends to bridge this gap by evaluating the incidence of micronutrient deficiencies, along with biochemical and clinical outcomes, and patient compliance over 12 months between individuals receiving specialized Elan supplements and those utilizing standard multivitamins following SG, RYGB, and OAGB. This trial will stratify its analysis based on the type of surgery to assess the differential impacts of supplementation per the distinct anatomical and absorptive characteristics of these three procedures.
- Conditions
- Vitamin Deficiencies
- Being tested
- Elan Believe, Elan Compass, Elan Supreme, Standard Multivitamins
- Keywords
- Elan Specialized Bariatric Supplements, Standard Multivitamins, Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, One-Anastomosis Gastric Bypass
- Medical subject headings
- Avitaminosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elan BelieveDietary supplement
Elan Believe is formulated specifically for patients undergoing SG and contains 18 mg of elemental zinc.
Elan CompassDietary supplement
Elan Compass is tailored for RYGB and contains 24 mg of zinc.
Elan SupremeDietary supplement
Designed for OAGB, provides 36 mg of zinc.
Standard MultivitaminsDietary supplement
Over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals. Unlike the specialized formulations, the standard multivitamin is not designed to accommodate the altered gastrointestinal absorption characteristics of post-MBS patients.
| Study group | Role | What they receive |
|---|---|---|
| Elan in Patients Undergoing Sleeve Gastrectomy | Active comparator | Patients undergoing sleeve gastrectomy and administrating Elan Specialized Bariatric Supplements (Elan Believe) Receives: Dietary Supplement: Elan Believe |
| Standard Multivitamins in Patients Undergoing Sleeve Gastrectomy | Active comparator | Patients undergoing sleeve gastrectomy and administrating Standard Multivitamins (over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals) Receives: Dietary Supplement: Standard Multivitamins |
| Elan in Patients Undergoing Roux-en-Y Gastric Bypass | Active comparator | Patients undergoing Roux-en-Y Gastric Bypass and administrating Elan Specialized Bariatric Supplements (Elan Compass) Receives: Dietary Supplement: Elan Compass |
| Standard Multivitamins in Patients Undergoing Roux-en-Y Gastric Bypass | Active comparator | Patients undergoing Roux-en-Y Gastric Bypass and administrating Standard Multivitamins (over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals) Receives: Dietary Supplement: Standard Multivitamins |
| Elan in Patients Undergoing One-Anastomosis Gastric Bypass | Active comparator | Patients undergoing One-Anastomosis Gastric Bypass and administrating Elan Specialized Bariatric Supplements (Elan Supreme) Receives: Dietary Supplement: Elan Supreme |
| Standard Multivitamins in Patients Undergoing One-Anastomosis Gastric Bypass | Active comparator | Patients undergoing One-Anastomosis Gastric Bypass and administrating Standard Multivitamins (over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals) Receives: Dietary Supplement: Standard Multivitamins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative micronutrient deficiencies at 3, 6, and 12 months following surgery.
Deficiencies will be assessed for six key micronutrients commonly affected by bariatric procedures: iron, vitamin B12, folate, vitamin D, calcium, and zinc. Thresholds for biochemical deficiency will be defined according to institutionally accepted reference ranges and international clinical guidelines. All measurements will be performed on fasting blood samples collected during scheduled follow-up visits.
Measured: 3, 6, and 12 months following surgery.
Secondary outcomes (6)
Measures of compliance
Will be assessed using a complementary method: monthly pill counts.
Measured: At 6 and 12 months
Measures of tolerability
Tolerability will be assessed through systematic reporting of adverse events, with particular attention to gastrointestinal symptoms that may impair adherence. Events will be recorded at each follow-up visit and classified according to severity and their potential relationship to the study supplement.
Measured: At 3, 6, and 12 months following surgery
Changes in biochemical markers (hemoglobin, ferritin, parathyroid hormone, and magnesium)
Biochemical outcomes will also include trends in hemoglobin, ferritin, parathyroid hormone (PTH), and magnesium levels over the 12-month follow-up period.
Measured: Over the 12-month follow-up period.
Anthropometric changes
Changes in BMI (weight and height will be combined to report BMI in kg/m^2) at 3, 6, and 12 months. (weight in kilograms, height in meters)
Measured: from enrollment till the end of the study (12 months)
Anthropometric changes
Changes in body weight and adiposity measure including %EWL (weight in kilograms) at 3, 6, and 12 months. %EWL is defined as the percentage of above-ideal body weight lost.
Measured: from enrollment till the end of the study (12 months)
Compliance with supplementation
Compliance with supplementation will be assessed using a complementary method: Validated five-item Medication Adherence Report Scale (MARS-5), administered at 6 and 12 months. The MARS-5 instrument evaluates common non-adherence patterns and yields a cumulative score ranging from 5 to 25, with higher scores indicating greater adherence. Participants will be categorized into three adherence levels: high (scores of 23 to 25), moderate (scores of 20 to 22), and low (scores below 20). These adherence classifications will be used to explore associations between adherence and clinical outcomes.
Measured: Administered at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start15 Jun 2025
- Primary completion14 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin DeficienciesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants enrolled in the trial will receive one of two oral multivitamin regimens for a total duration of 12 months, commencing on postoperative day 30. Within each surgical subgroup, including SG, RYGB, and OAGB, participants will be randomized in a 1:1 ratio to receive either a specialized bariatric supplement or a standard over-the-counter multivitamin. The specialized supplements, developed by Elan, include Elan Believe, Elan Compass, and Elan Supreme. Elan Believe is formulated specifically for patients undergoing SG, Elan Compass is tailored for RYGB and Elan Supreme, designed for OAGB. These zinc levels are aligned with ASMBS recommendations for SG and RYGB and slightly exceed the IFSO guideline of 30 mg/day for OAGB. The comparator supplement is a commercially available, over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021170
- Sponsor's protocol ID
- Elan vs Standard Multivitamins
- Status last verified
- Sep 2026
- First submitted
- 26 May 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The analysis will be performed on a blinded dataset after completing the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com), handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers where all the research data will be stored are certified according to ISO27001, ISO9001, and Dutch NEN7510. Can be asked by the contact person
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded Randomized Controlled Trial Comparing Elan Specialized Bariatric Supplements With Standard Multivitamins in Patients Undergoing Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, and One-Anastomosis Gastric Bypass
- ClinicalTrials.gov ID
- NCT07021170
- Acronym / sponsor ID
- Elan vs Standard Multivitamins
- Conditions
- Vitamin Deficiencies
- Keywords
- Elan Specialized Bariatric Supplements, Standard Multivitamins, Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, One-Anastomosis Gastric Bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 14 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 13 Jun 2025 (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.
Obesity has escalated to pandemic levels, impacting over 650 million adults globally and significantly contributing to the burden of non-communicable diseases such as type 2 diabetes, cardiovascular disease, obstructive sleep apnea, non-alcoholic fatty liver disease, and infertility. The chronic, multifactorial nature of obesity presents substantial challenges for long-term management, as lifestyle modifications and pharmacotherapy often yield limited and transient success. In this context, Metabolic and bariatric surgery (MBS) has emerged as the most effective and enduring treatment for obesity, offering significant weight loss and marked improvement or remission of obesity-related comorbidities.
The most prevalent MBS procedures include sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one-anastomosis gastric bypass (OAGB). While these interventions offer considerable metabolic advantages, they inherently cause significant modifications to gastrointestinal anatomy and physiology, which can predispose patients to long-term micronutrient deficiencies. These deficiencies can stem from reduced dietary intake, altered gastric acid secretion, decreased intrinsic factor production, and the bypassing of critical absorptive sites in the gastrointestinal tract. Commonly affected nutrients encompass iron, vitamin B12, Vitamin B6, folate, vitamin D, calcium, and zinc. If not effectively managed, these nutrient deficiencies can lead to anemia, secondary hyperparathyroidism, osteopenia, neurological complications, immune dysfunction, and impaired postoperative recovery.
Population-based recommended dietary allowances (RDAs) and tolerable upper intake levels (ULs) tend to underestimate the nutritional requirements for postoperative patients, as they are derived from healthy cohorts. Many standard formulations may fall short due to inadequate dosages, non-bioavailable forms, or poor tolerability, which can significantly impact patient adherence to supplementation regimens. Over-the-counter multivitamins, such as Centrum®, are designed for the general population and often lack the dosing, bioavailability, or elemental forms required for post-MBS physiology, particularly following bypass procedures.
The American Society for Metabolic and Bariatric Surgery (ASMBS) recommends 8-22 mg of elemental zinc per day, depending on the procedure, and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) and the World Gastroenterology Organization (WGO) recommend up to 30 mg/day for OAGB patients. These values are below the national upper limit in Egypt, which is 25 mg/day.
Moreover, there is evidence indicating a discrepancy in nutrient deficiencies among different bariatric surgery patients; for instance, OAGB patients exhibit a greater prevalence of iron and zinc deficiencies compared to those undergoing RYGB or SG, thereby necessitating proportionally higher supplementation tailored to their specific needs.
Detailed description
Consequently, specialized supplements containing adjusted doses of iron, zinc, and copper, within or slightly exceeding international guideline recommendations, are proposed to address the heightened risk of deficiencies, particularly in MBS procedures such as RYGB and OAGB, which are both clinically necessary and scientifically supported. In response to these shortcomings, specialized MBS supplements have been formulated to meet the unique physiological requirements and anatomical changes associated with each surgical procedure. The Elan Bariatric Supplement line, featuring Elan Believe for sleeve gastrectomy, Elan Compass for Roux-en-Y gastric bypass, and Elan Supreme for omega-loop gastric bypass, illustrates this tailored approach. It combines procedure-specific formulations aimed at optimizing nutrient absorption, minimizing gastrointestinal side effects, and enhancing patient compliance.
Despite the theoretical benefits of these specialized formulations, robust evidence supporting their clinical superiority over standard multivitamins remains scarce. Randomized controlled trials are warranted to ascertain whether these tailored supplements lead to improved nutritional status, enhanced tolerability, and superior overall outcomes in the post-MBS population. The present study intends to bridge this gap by evaluating the incidence of micronutrient deficiencies, along with biochemical and clinical outcomes, and patient compliance over 12 months between individuals receiving specialized Elan supplements and those utilizing standard multivitamins following SG, RYGB, and OAGB. This trial will stratify its analysis based on the type of surgery to assess the differential impacts of supplementation per the distinct anatomical and absorptive characteristics of these three procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- Participants enrolled in the trial will receive one of two oral multivitamin regimens for a total duration of 12 months, commencing on postoperative day 30. Within each surgical subgroup, including SG, RYGB, and OAGB, participants will be randomized in a 1:1 ratio to receive either a specialized bariatric supplement or a standard over-the-counter multivitamin. The specialized supplements, developed by Elan, include Elan Believe, Elan Compass, and Elan Supreme. Elan Believe is formulated specifically for patients undergoing SG, Elan Compass is tailored for RYGB and Elan Supreme, designed for OAGB. These zinc levels are aligned with ASMBS recommendations for SG and RYGB and slightly exceed the IFSO guideline of 30 mg/day for OAGB. The comparator supplement is a commercially available, over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals.
| Arm | Type | Receives |
|---|---|---|
| Elan in Patients Undergoing Sleeve Gastrectomy | Active comparator | Dietary Supplement: Elan BelievePatients undergoing sleeve gastrectomy and administrating Elan Specialized Bariatric Supplements (Elan Believe) |
| Standard Multivitamins in Patients Undergoing Sleeve Gastrectomy | Active comparator | Dietary Supplement: Standard MultivitaminsPatients undergoing sleeve gastrectomy and administrating Standard Multivitamins (over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals) |
| Elan in Patients Undergoing Roux-en-Y Gastric Bypass | Active comparator | Dietary Supplement: Elan CompassPatients undergoing Roux-en-Y Gastric Bypass and administrating Elan Specialized Bariatric Supplements (Elan Compass) |
| Standard Multivitamins in Patients Undergoing Roux-en-Y Gastric Bypass | Active comparator | Dietary Supplement: Standard MultivitaminsPatients undergoing Roux-en-Y Gastric Bypass and administrating Standard Multivitamins (over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals) |
| Elan in Patients Undergoing One-Anastomosis Gastric Bypass | Active comparator | Dietary Supplement: Elan SupremePatients undergoing One-Anastomosis Gastric Bypass and administrating Elan Specialized Bariatric Supplements (Elan Supreme) |
| Standard Multivitamins in Patients Undergoing One-Anastomosis Gastric Bypass | Active comparator | Dietary Supplement: Standard MultivitaminsPatients undergoing One-Anastomosis Gastric Bypass and administrating Standard Multivitamins (over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 65 years
- Capable of providing informed consent
- Willing to comply with study procedures and follow-up visits over 12 months.
- Candidates must have no prior history of MBS or gastrointestinal surgery and must be scheduled for one of the three aforementioned primary procedures.
- Both male and female patients will be considered, and no restrictions will be placed based on ethnicity or socioeconomic status.
Key exclusion criteria (6 listed)
- The presence of chronic conditions that may independently affect micronutrient metabolism or absorption, such as chronic kidney disease, inflammatory bowel disease, or hepatic insufficiency.
- Additional exclusion criteria include pregnancy or lactation at the time of enrollment
- Plans for pregnancy within the study period
- Active malignancy
- Any use of investigational drugs or supplements within the past 30 days.
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 |
|---|---|---|
| Elan BelieveElan Believe is formulated specifically for patients undergoing SG and contains 18 mg of elemental zinc. | Dietary supplement | Elan in Patients Undergoing Sleeve Gastrectomy |
| Elan CompassElan Compass is tailored for RYGB and contains 24 mg of zinc. | Dietary supplement | Elan in Patients Undergoing Roux-en-Y Gastric Bypass |
| Elan SupremeDesigned for OAGB, provides 36 mg of zinc. | Dietary supplement | Elan in Patients Undergoing One-Anastomosis Gastric Bypass |
| Standard MultivitaminsOver-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals. Unlike the specialized formulations, the standard multivitamin is not designed to accommodate the altered gastrointestinal absorption characteristics of post-MBS patients. | Dietary supplement | Standard Multivitamins in Patients Undergoing One-Anastomosis Gastric Bypass, Standard Multivitamins in Patients Undergoing Roux-en-Y Gastric Bypass, Standard Multivitamins in Patients Undergoing Sleeve Gastrectomy |
Primary outcome
Incidence of postoperative micronutrient deficiencies at 3, 6, and 12 months following surgery.
Time frame: 3, 6, and 12 months following surgery.
Deficiencies will be assessed for six key micronutrients commonly affected by bariatric procedures: iron, vitamin B12, folate, vitamin D, calcium, and zinc. Thresholds for biochemical deficiency will be defined according to institutionally accepted reference ranges and international clinical guidelines. All measurements will be performed on fasting blood samples collected during scheduled follow-up visits.
6 secondary outcomes
Measures of compliance
Time frame: At 6 and 12 months
Measures of tolerability
Time frame: At 3, 6, and 12 months following surgery
Changes in biochemical markers (hemoglobin, ferritin, parathyroid hormone, and magnesium)
Time frame: Over the 12-month follow-up period.
Anthropometric changes
Time frame: from enrollment till the end of the study (12 months)
Anthropometric changes
Time frame: from enrollment till the end of the study (12 months)
Compliance with supplementation
Time frame: Administered at 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. The analysis will be performed on a blinded dataset after completing the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com), handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers where all the research data will be stored are certified according to ISO27001, ISO9001, and Dutch NEN7510. Can be asked by the contact person
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elan Believe, Elan Compass and Elan Supreme in people with Vitamin Deficiencies, run by General Committee of Teaching Hospitals and Institutes, Egypt 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 2 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative micronutrient deficiencies at 3, 6, and 12 months following surgery. (time frame: 3, 6, and 12 months following 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 2 Sep 2026.