Ignite Creation Date:
2025-12-18 @ 8:18 AM
Ignite Modification Date:
2025-12-23 @ 6:57 PM
Study NCT ID:
NCT06983223
Status:
None
Last Update Posted:
2025-12-10 00:00:00
First Post:
2025-05-12 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Sucrosomial® Vitamin B12 in the Management of B12 Deficiency Among Metformin-Treated Type 2 Diabetes Patients
Sponsor:
None
Organization:
Study Overview
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
Status:
None
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: