Micronutrient DeficienciesPhase 4NCT06981936

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

A Phase 4 study testing Balance Tablet in people with Micronutrient Deficiencies, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Micronutrient Deficiencies
What is being tested?: Balance Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteEgypt
Study dates: 15 May 2025to 29 May 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

• 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.

Who cannot join

• 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Facility Name: The surgical department of Medical Research Institute Hospital, Alexandria University, Alexandria, Facility
Alexandria

Other trials in Egypt

About this study

Official title: Evaluation of Balance Tablets in Reducing Vitamin and Mineral Deficiencies in Patients Using GLP-1 Receptor Agonists for Weight Loss

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.

Read the 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.

Conditions: Micronutrient Deficiencies
Being tested: Balance Tablet, Control (placebo)
Keywords: Balance Tablets, Vitamin and Mineral Deficiencies, GLP-1 Receptor Agonists for Weight Loss, Weight Loss, Micronutrient Deficiencies
Medical subject headings: Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Balance TabletDrug
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)Drug
The placebo is an inert pill formulated to be indistinguishable from the Balance tablet in appearance, weight, and taste.

Study groups in NCT06981936
Study group	Role	What they receive
Intervention (Balance Tablet) Group	Experimental	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). Receives: Drug: Balance Tablet
Control (Placebo) Group	Placebo comparator	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. Receives: Drug: Control (placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of vitamin and mineral deficiencies at 12 months, comparing the proportion of participants in each group who develop one or more deficiencies.
Deficiency is defined for each nutrient as a serum concentration below the lower limit of the normal reference range (see Definitions below). The incidence of deficiencies will also be measured at interim time points (3, 6, and 9 months) to observe the trajectory over time, but the comparison at 12 months is the primary endpoint for efficacy.
Measured: From enrollment to the end of treatment at 12 months

Secondary outcomes (6)

Serum nutrient levels
Changes in specific vitamin and mineral concentrations from baseline at 3, 6, 9, and 12 months. This includes vitamins B_12, B_1 (thiamine), B_6 (pyridoxine), folic acid, 25-hydroxyvitamin D (25-OHD), and minerals such as iron stores (ferritin), calcium (albumin-corrected), magnesium, phosphate, zinc, as well as parathyroid hormone (PTH) and albumin (as a marker of nutritional status). For each of these analytes, the mean (or median) change over 12 months and the proportion of patients below normal range at each time point will be compared between groups.
Measured: From enrollment to the end of treatment at 12 months
Incidence of hypervitaminosis
Number and proportion of participants in each group who develop hypervitaminosis (excess levels of any vitamin above the normal reference range) during the 12-month period. This will be assessed at the same blood sampling intervals. Particularly, fat-soluble vitamin levels (e.g., vitamins A, D, B_12) will be monitored for any values above the upper limit of normal.
Measured: From enrollment to the end of treatment at 12 months
Compliance with supplementation
Adherence to the prescribed daily tablet regimen will be evaluated utilizing the 5-item Medication Adherence Report Scale (MARS-5), a validated instrument that identifies prevalent non-adherence patterns. Each of the five items will be rated on a 5-point Likert scale from 1 (indicating 'always') to 5 (indicating 'never'), yielding a cumulative score ranging from 5 to 25, where higher scores reflect improved adherence. At each designated follow-up interval (3, 6, 9, and 12 months), a bilingual study specialist will administer the MARS-5 questionnaire orally in the participant's preferred language, either Arabic or English, and meticulously document the responses. Comparative analyses of average adherence scores will be conducted between the Balance and placebo cohorts, and we will also assess the correlation between adherence levels and the occurrence of vitamin and mineral deficiencies.
Measured: From enrollment to the end of treatment at 12 months
Anthropometric outcome
Changes in body weight and adiposity measure including BMI (weight and height will be combined to report BMI in kg/m^2) at 3, 6, 9, and 12 months. That outcome will indicate the degree of weight loss and will be tracked to ensure both groups have similar weight loss (since all are on GLP-1 therapy) and to explore if improved micronutrient status correlates with better weight outcomes or vice versa. (weight in kilograms, height in meters)
Measured: From enrollment to the end of treatment at 12 months
Anthropometric outcome
Changes in body weight and adiposity measure including %EWL (weight in kilograms) at 3, 6, 9, and 12 months. %EWL is defined as the percentage of above-ideal body weight lost. That outcome will indicate the degree of weight loss and will be tracked to ensure both groups have similar weight loss (since all are on GLP-1 therapy) and to explore if improved micronutrient status correlates with better weight outcomes or vice versa.
Measured: From enrollment to the end of treatment at 12 months
Anthropometric outcome
Changes in body weight and adiposity measure including %TWL (weight in kilograms) at 3, 6, 9, and 12 months. %TWL is the percentage of total body weight lost from baseline. These outcomes will indicate the degree of weight loss and will be tracked to ensure both groups have similar weight loss (since all are on GLP-1 therapy) and to explore if improved micronutrient status correlates with better weight outcomes or vice versa.
Measured: From enrollment to the end of treatment at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 202529 May 2026

First posted21 May 2025
Study start15 May 2025
Primary completion21 May 2026
Study completion29 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Micronutrient 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 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.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06981936
Sponsor's protocol ID: Balance tablets And GLP1
Status last verified: Sep 2026
First submitted: 11 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Micronutrient Deficiencies trials

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: Evaluation of Balance Tablets in Reducing Vitamin and Mineral Deficiencies in Patients Using GLP-1 Receptor Agonists for Weight Loss
ClinicalTrials.gov ID: NCT06981936
Acronym / sponsor ID: Balance tablets And GLP1
Conditions: Micronutrient Deficiencies
Keywords: Balance Tablets, Vitamin and Mineral Deficiencies, GLP-1 Receptor Agonists for Weight Loss, Weight Loss, Micronutrient Deficiencies
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: General Committee of Teaching Hospitals and Institutes, EgyptOther government
Study start: 15 May 2025 (actual)
Primary completion: 21 May 2026 (actual)
Study completion: 29 May 2026 (actual)
First posted: 21 May 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.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
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.

Arm	Type	Receives
Intervention (Balance Tablet) Group	Experimental	Drug: Balance TabletParticipants 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	Placebo comparator	Drug: Control (placebo)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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

• Adults aged 18-65 years.

Key exclusion criteria (5 listed)

• 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).

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
Balance TabletEach 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).	Drug	Intervention (Balance Tablet) Group
Control (placebo)The placebo is an inert pill formulated to be indistinguishable from the Balance tablet in appearance, weight, and taste.	Drug	Control (Placebo) Group

Primary outcome

Incidence of vitamin and mineral deficiencies at 12 months, comparing the proportion of participants in each group who develop one or more deficiencies.
Time frame: From enrollment to the end of treatment at 12 months
Deficiency is defined for each nutrient as a serum concentration below the lower limit of the normal reference range (see Definitions below). The incidence of deficiencies will also be measured at interim time points (3, 6, and 9 months) to observe the trajectory over time, but the comparison at 12 months is the primary endpoint for efficacy.

6 secondary outcomes

Serum nutrient levels
Time frame: From enrollment to the end of treatment at 12 months
Incidence of hypervitaminosis
Time frame: From enrollment to the end of treatment at 12 months
Compliance with supplementation
Time frame: From enrollment to the end of treatment at 12 months
Anthropometric outcome
Time frame: From enrollment to the end of treatment at 12 months
Anthropometric outcome
Time frame: From enrollment to the end of treatment at 12 months
Anthropometric outcome
Time frame: From enrollment to the end of treatment at 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 Balance Tablet in people with Micronutrient 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 3 inclusion and 5 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. Some participants in this study may receive a placebo. 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 vitamin and mineral deficiencies at 12 months, comparing the proportion of participants in each group who develop one or more deficiencies. (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06981936.

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.