Oral Sucrosomial® Vitamin B12 in the Management of B12 Deficiency Among Metformin-Treated Type 2 Diabetes Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2025-12-03

Brief Summary

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This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Sucrosomial® Vitamin B12 supplementation in the management of vitamin B12 deficiency among metformin-treated Type 2 Diabetes Mellitus (T2DM) patients. The study will compare the impact of daily Sucrosomial® B12 (1,000 mcg) versus placebo on serum vitamin B12 levels, Holo-Transcobalamin II (HoloTCII), and Transcobalamin I (TCI) levels over a 4-week period. Secondary outcomes include assessment of safety, tolerability, and glycemic control (HbA1c). Fifty participants will be randomly assigned to either the Sucrosomial® B12 or placebo group.

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Detailed Description

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Vitamin B12 deficiency is a common concern in Type 2 Diabetes Mellitus (T2DM) patients, especially those treated with metformin, which is known to interfere with B12 absorption. Early identification and effective management of B12 deficiency are critical to prevent neurological and hematological complications.

This study is designed as a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of Sucrosomial® Vitamin B12 (1,000 mcg daily) compared to placebo in improving vitamin B12 status among metformin-treated T2DM patients. The study will enroll 50 participants (25 in each group) who will receive either Sucrosomial® B12 or placebo for 4 weeks.

Primary Outcome:

Change in serum vitamin B12 levels from baseline to 3 weeks.

Secondary Outcomes:

Change in Holo-Transcobalamin II (HoloTCII) levels from baseline to 3 weeks.

Change in Transcobalamin I (TCI) levels from baseline to 3 weeks.

Safety and tolerability, assessed through adverse event monitoring.

Change in glycemic control (HbA1c) from baseline to 3 weeks.

The study will include assessments at Baseline, 24 hours, 7 days, 14 days, and 21 days. Blood samples will be collected at each time point to measure vitamin B12, HoloTCII, TCI, CBC, LFTs, and RFTs. The safety profile will be monitored throughout the study.

This study will provide essential data on the effectiveness of Sucrosomial® B12 in improving vitamin B12 status among metformin-treated T2DM patients, offering a potential non-invasive intervention for managing B12 deficiency in this population.

Conditions

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Vitamin B 12 Deficiency Type 2 Diabetes Mellitus (T2DM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomly assigned in a 1:1 ratio to receive either Sucrosomial® B12 (1,000 mcg) or placebo once daily for 4 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The study will be double-blind, meaning neither the participants, care providers, investigators, nor outcomes assessors will know the treatment allocation.

Sucrosomial® B12 and placebo will be identical in appearance, packaging, and labeling to maintain blinding.

Study Groups

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Placebo Group

Participants in this group will receive a matching placebo (identical in appearance, packaging, and taste), administered as an orally dissolving powder, once daily for 3 weeks.

Dosage Form: Orally dissolving powder (sachet)

Administration Route: Oral

Frequency: Once daily

Duration: 3 weeks (21 days)

Group Type PLACEBO_COMPARATOR

Placebo (Oral)

Intervention Type OTHER

Participants in the placebo group will receive an identical powder that matches the Sucrosomial® B12 in appearance, packaging, and administration. The placebo will be administered once daily for 3 weeks.

Sucrosomial® B12 Group

Participants in this group will receive Sucrosomial® Vitamin B12 (1,000 mcg), administered as an orally dissolving powder, once daily for 3 weeks.

Dosage Form: Orally dissolving powder (sachet) Administration Route: Oral

Frequency: Once daily

Duration: 3 weeks (21 days)

Group Type EXPERIMENTAL

Sucrosomial® Vitamin B12

Intervention Type DIETARY_SUPPLEMENT

Sucrosomial® B12 is an advanced oral vitamin B12 supplement formulated with Sucrosomial® technology to enhance absorption. Participants in this group will receive 1,000 mcg of Sucrosomial® B12 (single sachet of orally dissolving powder) once daily for 3 weeks.

Interventions

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Sucrosomial® Vitamin B12

Sucrosomial® B12 is an advanced oral vitamin B12 supplement formulated with Sucrosomial® technology to enhance absorption. Participants in this group will receive 1,000 mcg of Sucrosomial® B12 (single sachet of orally dissolving powder) once daily for 3 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo (Oral)

Participants in the placebo group will receive an identical powder that matches the Sucrosomial® B12 in appearance, packaging, and administration. The placebo will be administered once daily for 3 weeks.

Intervention Type OTHER

Other Intervention Names

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Oral Sucrosomial® Vitamin B12 Matching Placebo

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 to 75 years.
* Diagnosed with Type 2 Diabetes Mellitus (T2DM).
* Currently on Metformin therapy for at least one year.
* Serum vitamin B12 levels below the laboratory reference range (indicating deficiency).
* Willing to provide written informed consent.
* Able to comply with study procedures and visit schedule.

Exclusion Criteria

* Current or prior use of vitamin B12 supplements within the past 3 months.
* Diagnosis of pernicious anemia or other causes of vitamin B12 malabsorption (e.g., Crohn's disease, celiac disease).
* History of gastric surgery or small intestine resection.
* Use of medications known to interfere with vitamin B12 absorption (other than Metformin).
* Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or end-stage renal disease.
* Severe hepatic impairment (ALT/AST \> 3 times the upper limit of normal).
* Pregnant or breastfeeding women.
* Known hypersensitivity to vitamin B12 or any component of the study product.
* Participation in another clinical trial within the last 30 days.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No