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

Not Applicable

Not yet recruiting

• Conditions: Vitamin B 12 Deficiency; Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT06983223
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief Summary

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.

Detailed Description

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 4 weeks.

Secondary Outcomes:

Change in Holo-Transcobalamin II (HoloTCII) levels from baseline to 4 weeks.

Change in Transcobalamin I (TCI) levels from baseline to 4 weeks.

Safety and tolerability, assessed through adverse event monitoring.

Change in glycemic control (HbA1c) from baseline to 4 weeks.

The study will include assessments at Baseline, 24 hours, 7 days, 14 days, and 30 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-06-30
• Primary Completion: 2025-09-15
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Serum Vitamin B12 Levels	Baseline, 24 hours, 7 days, 14 days, and 30 days.	Assessment of change in serum vitamin B12 levels from baseline to 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Change in Holo-Transcobalamin II (HoloTCII) Levels	Baseline, 24 hours, 7 days, 14 days, and 30 days.	Change in Holo-Transcobalamin II (HoloTCII) Levels
Change in Transcobalamin I (TCI) Levels	Baseline, 24 hours, 7 days, 14 days, and 30 days.	Assessment of Transcobalamin I (TCI) levels to evaluate the impact of Sucrosomial® B12 supplementation on vitamin B12 binding proteins. Blood samples will be collected at baseline, 24 hours, 7 days, 14 days, and 30 days.
Change in Glycemic Control (HbA1c)	Baseline and 30 days.	Measurement of HbA1c to assess the impact of Sucrosomial® B12 supplementation on glycemic control in metformin-treated Type 2 Diabetes patients.
Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Sucrosomial® B12)	Continuous monitoring throughout the 4-week intervention.	Assessment of adverse events and side effects reported by participants during the 4-week intervention period. This includes the number of participants with one or more treatment-emergent adverse events (TEAEs), their severity (mild, moderate, severe), and the investigator-assessed relationship to the study product (Sucrosomial® B12).
Change in Complete Blood Count (CBC)	Baseline and 30 days.	Monitoring of hematological parameters (CBC) to assess safety of Sucrosomial® B12.
Change in Liver Function Tests (LFTs)	Baseline and 30 days.	Evaluation of liver safety by measuring serum alanine transaminase (ALT), aspartate transaminase (AST), and total bilirubin levels at Baseline and Day 30 using standard automated clinical chemistry analyzers. Changes in these parameters will be used to assess hepatic response to Sucrosomial® B12.
Change in Serum Creatinine and Blood Urea Nitrogen (BUN) Levels (Renal Function Tests)	Baseline and 30 days.	Evaluation of renal safety by measuring serum creatinine and blood urea nitrogen (BUN) levels at Baseline and Day 30 using standard laboratory methods. These values will be analyzed to detect any changes associated with Sucrosomial® B12 administration.

Trial Locations

Locations (1)

Liaquat University of Medical & Health Sciences (LUMHS); 🇵🇰 Jāmshoro, Sindh, Pakistan