Status:
COMPLETED
Oral Sucrosomial® Vitamin B12 in the Management of B12 Deficiency Among Metformin-Treated Type 2 Diabetes Patients
Lead Sponsor:
Liaquat University of Medical & Health Sciences
Conditions:
Vitamin B 12 Deficiency
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18-75 years
Phase:
NA
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 metfor...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06983223
Start Date
August 15 2025
End Date
December 3 2025
Last Update
December 10 2025
Active Locations (1)
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1
Liaquat University of Medical & Health Sciences (LUMHS)
Jāmshoro, Sindh, Pakistan, 76090