NCT06983223Completed
Oral Sucrosomial® Vitamin B12 in the Management of B12 Deficiency Among Metformin-Treated Type 2 Diabetes Patients
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
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 12 May 2025
- Start date
- 15 Aug 2025
- Primary completion date
- 3 Dec 2025
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Diseases
- Type 2 diabetes
- NCT number
- NCT06983223
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 15 Aug 2025 to the primary completion date, 3 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior use of vitamin B12 supplements within the past 3 months.
- Use of medications known to interfere with vitamin B12 absorption (other than Metformin).
Other illness
- 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.
- Known hypersensitivity to vitamin B12 or any component of the study product.
Lab values
- 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).
Other
- Pregnant or breastfeeding women.
- Participation in another clinical trial within the last 30 days.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liaquat University of Medical & Health Sciences (LUMHS) Coordinator of this site? Confirm its status | Jamshoro | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.