Oral Sucrosomial® Vitamin B12 in the Management of B12 Deficiency Among Metformin-Treated Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Pakistan
Liaquat University of Medical & Health Sciences (LUMHS)
RECRUITING
Jāmshoro
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 50
Treatments
Experimental: Sucrosomial® B12 Group
Participants in this group will receive Sucrosomial® Vitamin B12 (1,000 mcg), administered as an orally dissolving powder, once daily for 4 weeks.~Dosage Form: Orally dissolving powder (sachet) Administration Route: Oral~Frequency: Once daily~Duration: 4 weeks (30 days)
Placebo_comparator: 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 4 weeks.~Dosage Form: Orally dissolving powder (sachet)~Administration Route: Oral~Frequency: Once daily~Duration: 4 weeks (30 days)
Related Therapeutic Areas
Transcobalamin Deficiency
Vitamin B12 Deficiency
Type 2 Diabetes (T2D)
Malnutrition
Vitamin B12 Deficiency Anemia
Sponsors
Leads: Liaquat University of Medical & Health Sciences

This content was sourced from clinicaltrials.gov

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