Clinical trial NCT06983223: Oral Sucrosomial® Vitamin B12 in the Management of B12 Deficiency Among Metformin-Treated Type 2 Diabetes Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vitamin B 12 Deficiency
Type 2 Diabetes Mellitus (T2DM)
Keywords: Metformin-Associated Vitamin B12 Deficiency
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomly assigned in a 1:1 ratio to receive either Sucrosomial® B12 (1,000 mcg) or placebo once daily for 4 weeks.
Primary purpose: TREATMENT

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 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.

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 and effective management of B12 deficiency are critical to prevent neurological and hematological complications.

This study is designed as a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of Sucrosomial® Vitamin B12 (1,000 mcg daily) compared to placebo in improving vitamin B12 status among metformin-treated T2DM patients. The study will enroll 50 participants (25 in each group) who will receive either Sucrosomial® B12 or placebo for 4 weeks.

Primary Outcome:

Change in serum vitamin B12 levels from baseline to 4 weeks.

Secondary Outcomes:

Change in Holo-Transcobalamin II (HoloTCII) levels from baseline to 4 weeks.

Change in Transcobalamin I (TCI) levels from baseline to 4 weeks.

Safety and tolerability, assessed through adverse event monitoring.

Change in glycemic control (HbA1c) from baseline to 4 weeks.

The study will include assessments at Baseline, 24 hours, 7 days, 14 days, and 30 days. Blood samples will be collected at each time point to measure vitamin B12, HoloTCII, TCI, CBC, LFTs, and RFTs. The safety profile will be monitored throughout the study.

This study will provide essential data on the effectiveness of Sucrosomial® B12 in improving vitamin B12 status among metformin-treated T2DM patients, offering a potential non-invasive intervention for managing B12 deficiency in this population.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Serum Vitamin B12 Levels
timeFrame: Baseline, 24 hours, 7 days, 14 days, and 30 days.
Secondary outcomes:
measure: Change in Holo-Transcobalamin II (HoloTCII) Levels
timeFrame: Baseline, 24 hours, 7 days, 14 days, and 30 days.
measure: Change in Transcobalamin I (TCI) Levels
timeFrame: Baseline, 24 hours, 7 days, 14 days, and 30 days.
measure: Change in Glycemic Control (HbA1c)
timeFrame: Baseline and 30 days.
measure: Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Sucrosomial® B12)
timeFrame: Continuous monitoring throughout the 4-week intervention.
measure: Change in Complete Blood Count (CBC)
timeFrame: Baseline and 30 days.
measure: Change in Liver Function Tests (LFTs)
timeFrame: Baseline and 30 days.
measure: Change in Serum Creatinine and Blood Urea Nitrogen (BUN) Levels (Renal Function Tests)
timeFrame: Baseline and 30 days.
Other outcomes:
Locations:
city: Jāmshoro
country: Pakistan
facility: Liaquat University of Medical & Health Sciences (LUMHS)
state: Sindh
Study officials:
References:
citation: Memon NM, Conti G, Brilli E, Tarantino G, Chaudhry MNA, Baloch A, Shafiq A, Mumtaz SU, Qaisar W, Iqtadar S, Abrar S, Kanwal A, Akhtar MH, Latif H, Rabbani F, Ujjan ID, Turroni S, Khan A. Comparative bioavailability study of supplemental oral Sucrosomial (R) vs. oral conventional vitamin B12 in enhancing circulatory B12 levels in healthy deficient adults: a multicentre, double-blind randomized clinical trial. Front Nutr. 2024 Nov 8;11:1493593. doi: 10.3389/fnut.2024.1493593. eCollection 2024.
citation: Alhaji JH. Vitamin B12 Deficiency in Patients with Diabetes on Metformin: Arab Countries. Nutrients. 2022 May 13;14(10):2046. doi: 10.3390/nu14102046.
citation: Sayedali E, Yalin AE, Yalin S. Association between metformin and vitamin B12 deficiency in patients with type 2 diabetes. World J Diabetes. 2023 May 15;14(5):585-593. doi: 10.4239/wjd.v14.i5.585.
citation: Bell DSH. Metformin-induced vitamin B12 deficiency can cause or worsen distal symmetrical, autonomic and cardiac neuropathy in the patient with diabetes. Diabetes Obes Metab. 2022 Aug;24(8):1423-1428. doi: 10.1111/dom.14734. Epub 2022 May 20.
citation: Gupta K, Jain A, Rohatgi A. An observational study of vitamin b12 levels and peripheral neuropathy profile in patients of diabetes mellitus on metformin therapy. Diabetes Metab Syndr. 2018 Jan-Mar;12(1):51-58. doi: 10.1016/j.dsx.2017.08.014. Epub 2017 Aug 25.