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Oral Sucrosomial® Vitamin B12 in the Management of B12 Deficiency Among Metformin-Treated Type 2 Diabetes Patients
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.
Details
| Lead sponsor | Liaquat University of Medical & Health Sciences |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 50 |
| Start date | Fri Aug 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Dec 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Vitamin B 12 Deficiency
- Type 2 Diabetes Mellitus (T2DM)
Interventions
- Sucrosomial® Vitamin B12
- Placebo (Oral)
Countries
Pakistan