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

NCT06983223 | Completed DMC

• 1 other identifier: LUMHS/REC/-733/09.05.2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Metformin-Associated Vitamin B12 Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in Serum Vitamin B12 Levels

  Assessment of change in serum vitamin B12 levels from baseline to 3 weeks.

  Baseline, 24 hours, 7 days, 14 days, and 21 days.

Secondary Outcomes (5)

• Change in Holo-Transcobalamin II (HoloTCII) Levels

  Baseline, 24 hours, 7 days, 14 days, and 21 days.

• Change in Transcobalamin I (TCI) Levels

  Baseline, 24 hours, 7 days, 14 days, and 21 days.

• Change in Gastric intrinsic factor levels

  Baseline, 24 hours, 7 days, 14 days, and 21 days.

• Change in Holotranscobalamin (active B12) Levels

  Baseline, 24 hours, 7 days, 14 days, and 21 days.

• Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Sucrosomial® B12)

  Continuous monitoring throughout the 3-week intervention.

Study Arms (2)

Sucrosomial® B12 Group

EXPERIMENTAL

Participants in this group will receive Sucrosomial® Vitamin B12 (1,000 mcg), administered as an orally dissolving powder, once daily for 3 weeks. Dosage Form: Orally dissolving powder (sachet) Administration Route: Oral Frequency: Once daily Duration: 3 weeks (21 days)

Dietary Supplement: Sucrosomial® Vitamin B12

Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive a matching placebo (identical in appearance, packaging, and taste), administered as an orally dissolving powder, once daily for 3 weeks. Dosage Form: Orally dissolving powder (sachet) Administration Route: Oral Frequency: Once daily Duration: 3 weeks (21 days)

Other: Placebo (Oral)

Interventions

Placebo (Oral) OTHER

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.

Also known as: Matching Placebo

Placebo Group

Sucrosomial® Vitamin B12 DIETARY_SUPPLEMENT

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.

Also known as: Oral Sucrosomial® Vitamin B12

Sucrosomial® B12 Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead

Study Sites (1)

Liaquat University of Medical & Health Sciences (LUMHS)

Jāmshoro, Sindh, 76090, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 39582666 BACKGROUND

• Alhaji JH. Vitamin B12 Deficiency in Patients with Diabetes on Metformin: Arab Countries. Nutrients. 2022 May 13;14(10):2046. doi: 10.3390/nu14102046.

  PMID: 35631186 BACKGROUND

• 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.

  PMID: 37273250 BACKGROUND

• 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.

  PMID: 35491956 BACKGROUND

• 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.

  PMID: 28882470 BACKGROUND

MeSH Terms

Conditions

Vitamin B 12 Deficiency; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be double-blind, meaning neither the participants, care providers, investigators, nor outcomes assessors will know the treatment allocation. Sucrosomial® B12 and placebo will be identical in appearance, packaging, and labeling to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 21, 2025
• Study Start: August 15, 2025
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)