Trial Comparing Elan Specialized Bariatric Supplements With Standard Multivitamins in Patients Undergoing Bariatric Procedures

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGeneral Committee of Teaching Hospitals and Institutes, Egypt

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Elan Believe

    Dietary supplement

    Elan Believe is formulated specifically for patients undergoing SG and contains 18 mg of elemental zinc.

  • Elan Compass

    Dietary supplement

    Elan Compass is tailored for RYGB and contains 24 mg of zinc.

  • Elan Supreme

    Dietary supplement

    Designed for OAGB, provides 36 mg of zinc.

  • Standard Multivitamins

    Dietary 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.

Treatment groups

624 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Elan in Patients Undergoing Sleeve GastrectomyActive comparator 1 intervention
Group B: Standard Multivitamins in Patients Undergoing Sleeve GastrectomyActive comparator 1 intervention
Group C: Elan in Patients Undergoing Roux-en-Y Gastric BypassActive comparator 1 intervention
Group D: Standard Multivitamins in Patients Undergoing Roux-en-Y Gastric BypassActive comparator 1 intervention
Group E: Elan in Patients Undergoing One-Anastomosis Gastric BypassActive comparator 1 intervention
Group F: Standard Multivitamins in Patients Undergoing One-Anastomosis Gastric BypassActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3, 6, and 12 months following surgery.

Secondary outcomes

1

Measures of compliance

Will be assessed using a complementary method: monthly pill counts.

Time frame
At 6 and 12 months
2

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.

Time frame
At 3, 6, and 12 months following surgery
3

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.

Time frame
Over the 12-month follow-up period.
4

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)

Time frame
from enrollment till the end of the study (12 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.