Oral Sucrosomial® Vitamin B12 in the Management of B12 Deficiency Among Metformin-Treated Type 2 … (NCT06983223) | Clinical Trial Compass
CompletedNot Applicable
Oral Sucrosomial® Vitamin B12 in the Management of B12 Deficiency Among Metformin-Treated Type 2 Diabetes Patients
Pakistan50 participantsStarted 2025-08-15
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.