Clinical trial NCT06981936: This Randomized Trial Aims to Investigate the Efficacy of Balanced Nutritional Tablets-Comprehensive Multivitamin and Mineral Supplements- in Preventing Micronutrient Deficiencies Among Patients Utilizing GLP-1 RAs for Weight Loss in Comparison to a Placebo Control
Official title: Evaluation of Balance Tablets in Reducing Vitamin and Mineral Deficiencies in Patients Using GLP-1 Receptor Agonists for Weight Loss
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Micronutrient Deficiencies
Keywords: Balance Tablets
Vitamin and Mineral Deficiencies
GLP-1 Receptor Agonists for Weight Loss
Weight Loss
Micronutrient Deficiencies
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2025-05-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two intervention arms:

* Intervention (Balance Tablet) Group: Participants take one Balance multivitamin/mineral tablet daily for 12 months. Each Balance tablet contains a broad range of vitamins and trace minerals at doses designed to prevent deficiencies (including but not limited to vitamins A, B-complex, C, D, E, K, calcium, iron, zinc, magnesium, selenium, and others, per standard multivitamin composition).
* Control (Placebo) Group: Participants take one placebo tablet daily for 12 months. The placebo is an inert pill formulated to be indistinguishable from the Balance tablet in appearance, weight, and taste.
* All participants will continue their prescribed GLP-1 RA therapy and any standard dietary advice for weight loss as per their treating provider. Compliance will be encouraged through monthly reminders and pill count checks; participants will be asked to return unused tablets at each study visit to monitor adherence.
Primary purpose: PREVENTION

Brief summary: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including Ozempic (semaglutide) and Saxenda (liraglutide), are gaining traction in treating obesity and its associated diseases due to their capacity to facilitate substantial weight loss through mechanisms such as appetite suppression and delayed gastric emptying. Clinical trials have consistently shown that patients prescribed GLP-1 RAs can achieve significant body weight reductions when combined with appropriate dosing and lifestyle modifications.

However, the chronic appetite suppression and reduced caloric intake associated with prolonged GLP-1 RA use may increase the risk of micronutrient deficiencies, paralleling the biochemical changes observed after metabolic and bariatric surgery (MBS). In MBS cohorts, insufficient dietary intake coupled with malabsorption frequently results in deficiencies of essential vitamins and minerals, even in patients adhering to standard multivitamin regimens.

Research has demonstrated that high-dose specialized multivitamin supplementation can substantially lower the incidence of postoperative micronutrient deficiencies in MBS patients. This raises the possibility that proactive nutrient supplementation might similarly benefit individuals undergoing weight loss with GLP-1 RAs, although this hypothesis remains to be empirically validated.

To address this gap, this randomized trial aims to investigate the efficacy of Balanced nutritional tablets-comprehensive multivitamin and mineral supplements- in preventing micronutrient deficiencies among patients utilizing GLP-1 RAs for weight loss in comparison to a placebo control. Moreover, the study will assess changes in key nutrient biomarkers and relevant clinical outcomes over 12 months.

Detailed description: Primary Objectives:

• Evaluate the efficacy of daily Balance multivitamin tablets in reducing the incidence of vitamin and mineral deficiencies among patients undergoing treatment with GLP-1 receptor agonists (RAs) for weight loss over 12 months, in comparison to a placebo group.

Secondary Objectives:

* Assessment of changes in serum concentrations of key vitamins and minerals such as vitamin B12, 25-hydroxyvitamin D, ferritin, and folate.
* comparing data collected at baseline with that gathered at the 12-month mark between the Balance multivitamin and placebo groups.
* Evaluate the effects of the intervention on body weight and various anthropometric measures, including Body Mass Index (BMI), percent excess weight loss (%EWL), and percent total body weight loss (%TWL), over the same 12-month period.
* Investigate the occurrence of hypervitaminosis, defined as elevated vitamin levels above normal ranges, within both intervention groups.
* Monitor adherence to the daily tablet regimen, ensuring compliance with the intervention protocol throughout the study duration.

Definitions

* Vitamin/Mineral Deficiency: For the purpose of this study, a deficiency is defined as a serum concentration below the lower limit of the standard laboratory reference range for that nutrient. Each participating laboratory will have established normal ranges for the measured vitamins and minerals; values below the 2.5th percentile of healthy individuals (the typical lower limit) will be considered deficient. For example, vitamin B_12 deficiency may be defined as B_12 \< 200 pg/mL and vitamin D deficiency as 25-OHD \< 20 ng/mL, based on commonly accepted thresholds, although the exact cut-off will depend on the assay reference range ￼. Participants will be considered to have a deficiency if any one or more of the tracked nutrients falls below the normal range at a given time point (excluding transient lab errors, which would be rechecked). Each distinct nutrient deficiency will also be recorded for analysis.
* Hypervitaminosis: Defined as a serum vitamin level above the upper limit of the normal reference range. For instance, vitamin B_6 above \~30 ng/mL or 25-OHD above \~100 ng/mL (depending on lab norms) would be flagged as potential hypervitaminosis. Any participant with a value above the normal range for a given vitamin at any time is noted as having hypervitaminosis (for that vitamin). The study intervention (Balance tablets) is formulated at standard recommended doses, so true hypervitaminosis is expected to be rare; however, tracking this ensures safety. If any levels are extremely high (e.g., \>2 times upper limit), study clinicians will be notified to evaluate the participant for over-supplementation or other causes.

Eligibility criteria: Inclusion Criteria:

* • Adults aged 18-65 years.

  * BMI ≥ 30 kg/m² (obesity), or BMI ≥ 27 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension).
  * Currently using a GLP-1 receptor agonist medication for weight management (e.g., semaglutide or liraglutide) and planning to continue it for the next year as part of their weight loss regimen.

Exclusion Criteria:

* • Any pre-existing condition that affects nutrient absorption or metabolism (e.g., malabsorptive gastrointestinal disorders such as celiac disease or inflammatory bowel disease, prior bariatric surgery).

  * Use of other weight loss medications (besides the GLP-1 RA) or use of high-dose vitamin/mineral supplements or other nutritional supplements that could influence vitamin/mineral status.
  * Pregnancy or lactation (women of childbearing potential will undergo a pregnancy test and must agree to use contraception during the study).
  * Known hypersensitivity or allergy to components of the Balance multivitamin formulation.
  * Significant chronic illnesses (e.g., end-stage renal disease, advanced liver disease) that in the investigator's judgment would interfere with participation or outcomes of the study.

Primary outcomes:
measure: Incidence of vitamin and mineral deficiencies at 12 months, comparing the proportion of participants in each group who develop one or more deficiencies.
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
measure: Serum nutrient levels
timeFrame: From enrollment to the end of treatment at 12 months
measure: Incidence of hypervitaminosis
timeFrame: From enrollment to the end of treatment at 12 months
measure: Compliance with supplementation
timeFrame: From enrollment to the end of treatment at 12 months
measure: Anthropometric outcome
timeFrame: From enrollment to the end of treatment at 12 months
measure: Anthropometric outcome
timeFrame: From enrollment to the end of treatment at 12 months
measure: Anthropometric outcome
timeFrame: From enrollment to the end of treatment at 12 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Facility Name: The surgical department of Medical Research Institute Hospital, Alexandria University, Alexandria, Facility
Study officials:
References: