Vitamin B 12 DeficiencyNCT06983223
Oral Sucrosomial® Vitamin B12 in the Management of B12 Deficiency Among Metformin-Treated Type 2 Diabetes Patients
A study testing Sucrosomial® Vitamin B12 in people with Vitamin B 12 Deficiency and Type 2 Diabetes Mellitus (T2DM), run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitamin B 12 Deficiency, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Sucrosomial® Vitamin B12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2025to 3 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Liaquat University of Medical & Health Sciences (LUMHS)
Jāmshoro, Sindh, 76090
About this study
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
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.
Read the 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 3 weeks.
Secondary Outcomes:
Change in Holo-Transcobalamin II (HoloTCII) levels from baseline to 3 weeks.
Change in Transcobalamin I (TCI) levels from baseline to 3 weeks.
Safety and tolerability, assessed through adverse event monitoring.
Change in glycemic control (HbA1c) from baseline to 3 weeks.
The study will include assessments at Baseline, 24 hours, 7 days, 14 days, and 21 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.
- Being tested
- Sucrosomial® Vitamin B12, Placebo (Oral)
- Keywords
- Metformin-Associated Vitamin B12 Deficiency
- Medical subject headings
- Vitamin B 12 Deficiency, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrosomial® Vitamin B12Dietary supplement
Also called Oral Sucrosomial® Vitamin B12
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.
Placebo (Oral)Other
Also called Matching Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Placebo (Oral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Vitamin B12 Levels
Assessment of change in serum vitamin B12 levels from baseline to 3 weeks.
Measured: Baseline, 24 hours, 7 days, 14 days, and 21 days.
Secondary outcomes (5)
Change in Holo-Transcobalamin II (HoloTCII) Levels
Change in Holo-Transcobalamin II (HoloTCII) Levels
Measured: Baseline, 24 hours, 7 days, 14 days, and 21 days.
Change in Transcobalamin I (TCI) Levels
Assessment of Transcobalamin I (TCI) levels to evaluate the impact of Sucrosomial® B12 supplementation on vitamin B12 binding proteins. Blood samples will be collected at baseline, 24 hours, 7 days, 14 days, and 21 days.
Measured: Baseline, 24 hours, 7 days, 14 days, and 21 days.
Change in Gastric intrinsic factor levels
Measurement of gastric intrinsic factor to assess the impact of Sucrosomial® B12 supplementation in metformin-treated Type 2 Diabetes patients.
Measured: Baseline, 24 hours, 7 days, 14 days, and 21 days.
Change in Holotranscobalamin (active B12) Levels
Measurement of Holotranscobalamin to assess the impact of Sucrosomial® B12 supplementation in metformin-treated Type 2 Diabetes patients.
Measured: Baseline, 24 hours, 7 days, 14 days, and 21 days.
Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Sucrosomial® B12)
Assessment of adverse events and side effects reported by participants during the 3-week intervention period. This includes the number of participants with one or more treatment-emergent adverse events (TEAEs), their severity (mild, moderate, severe), and the investigator-assessed relationship to the study product (Sucrosomial® B12).
Measured: Continuous monitoring throughout the 3-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start15 Aug 2025
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vitamin B 12 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983223
- Sponsor's protocol ID
- LUMHS/REC/-733/09.05.2025
- Status last verified
- Dec 2025
- First submitted
- 12 May 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39582666Alhaji JH. Vitamin B12 Deficiency in Patients with Diabetes on Metformin: Arab Countries. Nutrients. 2022 May 13;14(10):2046. doi: 10.3390/nu14102046.
PubMed 35631186Sayedali 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.
PubMed 37273250Bell 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.
PubMed 35491956Gupta 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.
PubMed 28882470
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06983223
- Acronym / sponsor ID
- LUMHS/REC/-733/09.05.2025
- Keywords
- Metformin-Associated Vitamin B12 Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 3 weeks.
Secondary Outcomes:
Change in Holo-Transcobalamin II (HoloTCII) levels from baseline to 3 weeks.
Change in Transcobalamin I (TCI) levels from baseline to 3 weeks.
Safety and tolerability, assessed through adverse event monitoring.
Change in glycemic control (HbA1c) from baseline to 3 weeks.
The study will include assessments at Baseline, 24 hours, 7 days, 14 days, and 21 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sucrosomial® B12 Group | Experimental | Dietary Supplement: Sucrosomial® Vitamin B12Participants 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) |
| Placebo Group | Placebo comparator | Other: Placebo (Oral)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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucrosomial® Vitamin B12Also: Oral Sucrosomial® Vitamin B12Sucrosomial® 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. | Dietary supplement | Sucrosomial® B12 Group |
| Placebo (Oral)Also: Matching PlaceboParticipants 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. | Other | Placebo Group |
Primary outcome
Change in Serum Vitamin B12 Levels
Time frame: Baseline, 24 hours, 7 days, 14 days, and 21 days.
Assessment of change in serum vitamin B12 levels from baseline to 3 weeks.
5 secondary outcomes
Change in Holo-Transcobalamin II (HoloTCII) Levels
Time frame: Baseline, 24 hours, 7 days, 14 days, and 21 days.
Change in Transcobalamin I (TCI) Levels
Time frame: Baseline, 24 hours, 7 days, 14 days, and 21 days.
Change in Gastric intrinsic factor levels
Time frame: Baseline, 24 hours, 7 days, 14 days, and 21 days.
Change in Holotranscobalamin (active B12) Levels
Time frame: Baseline, 24 hours, 7 days, 14 days, and 21 days.
Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Sucrosomial® B12)
Time frame: Continuous monitoring throughout the 3-week intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Background: PubMed 39582666Memon 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.
- Background: PubMed 35631186Alhaji JH. Vitamin B12 Deficiency in Patients with Diabetes on Metformin: Arab Countries. Nutrients. 2022 May 13;14(10):2046. doi: 10.3390/nu14102046.
- Background: PubMed 37273250Sayedali 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.
- Background: PubMed 35491956Bell 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.
- Background: PubMed 28882470Gupta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrosomial® Vitamin B12 in people with Vitamin B 12 Deficiency and Type 2 Diabetes Mellitus (T2DM), run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Vitamin B12 Levels (time frame: Baseline, 24 hours, 7 days, 14 days, and 21 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06983223, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.