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

NCT07021170 | Recruiting Phase 4

• 1 other identifier: Elan vs Standard Multivitamins
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vitamin Deficiencies

Keywords

Elan Specialized Bariatric Supplements; Standard Multivitamins; Sleeve Gastrectomy; Roux-en-Y Gastric Bypass; One-Anastomosis Gastric Bypass

Outcome Measures

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.

  3, 6, and 12 months following surgery.

Secondary Outcomes (6)

• Measures of compliance

  At 6 and 12 months

• Measures of tolerability

  At 3, 6, and 12 months following surgery

• Changes in biochemical markers (hemoglobin, ferritin, parathyroid hormone, and magnesium)

  Over the 12-month follow-up period.

• Anthropometric changes

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

• Anthropometric changes

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

Study Arms (6)

Elan in Patients Undergoing Sleeve Gastrectomy

ACTIVE COMPARATOR

Patients undergoing sleeve gastrectomy and administrating Elan Specialized Bariatric Supplements (Elan Believe)

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)

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)

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)

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)

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)

Dietary Supplement: Standard Multivitamins

Interventions

Elan Believe DIETARY_SUPPLEMENT

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

Elan in Patients Undergoing Sleeve Gastrectomy

Elan Compass DIETARY_SUPPLEMENT

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

Elan in Patients Undergoing Roux-en-Y Gastric Bypass

Elan Supreme DIETARY_SUPPLEMENT

Designed for OAGB, provides 36 mg of zinc.

Elan in Patients Undergoing One-Anastomosis Gastric Bypass

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The presence of chronic conditions that may independently affect micronutrient metabolism or absorption, such as chronic kidney disease, inflammatory bowel disease, or hepatic insufficiency.
• 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.

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, Alexandria Governorate, 21531, Egypt

RECRUITING

MeSH Terms

Conditions

Avitaminosis

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Mohamed Ashour, Ph.D. (Professor)

CONTACT

+201002600970; mohamed.ashour@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General surgery

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 13, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Whole study period
• Access Criteria: Ask contact person

Locations

EG (1)