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

NCT06983223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

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.

Sponsors & Collaborators

  • Liaquat University of Medical & Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2025-12-03
Completion
2025-12-03

Countries

  • Pakistan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06983223 on ClinicalTrials.gov