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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Serum Vitamin B12 Levels
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sucrosomial® B12 Group
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)
干预措施: Sucrosomial® Vitamin B12 (Dietary Supplement)
Placebo Group
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)
干预措施: Placebo (Oral) (Other)
结局指标
主要结局
Change in Serum Vitamin B12 Levels
时间窗: Baseline, 24 hours, 7 days, 14 days, and 21 days.
Assessment of change in serum vitamin B12 levels from baseline to 3 weeks.
次要结局
- 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.)
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental medicine
Liaquat University of Medical & Health Sciences