Sublingual Versus Oral Vitamin B12 for Acute Hypovitaminosis B12 Secondary to Proton Pump Inhibitors: A Prospective Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 23
- 主要终点
- Change in Serum Vitamin B12 Concentration
研究概览
简要总结
This randomized, clinical trial evaluates the efficacy of oral versus sublingual vitamin B12 supplementation in correcting early-onset vitamin B12 deficiency in adult patients using proton pump inhibitors (PPIs). The primary outcome is the change in serum vitamin B12 levels over a 6-week treatment period. Secondary outcomes include changes in homocysteine levels, hemoglobin levels, and patient-reported satisfaction.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PPI use for 1-6 months (new users).
- •Serum B12 between 150-300 pg/mL.
- •No known prior B12 supplementation.
排除标准
- •History of long-term GI disease (e.g., Crohn's, celiac).
- •Previous gastrectomy/bariatric surgery.
- •Baseline anemia with hemoglobin <9 g/dL.
- •Severe renal or liver failure.
研究组 & 干预措施
Oral Vitamin B12 Group
Participants in this arm will receive 1000 mcg oral cyanocobalamin daily for 6 weeks. The supplement will be administered as a swallowed tablet. Patients will continue their regular PPI therapy during the study period.
干预措施: Cyanocobalamin 1000 Mcg Oral Tablet (Drug)
Sublingual Vitamin B12 Group
Participants in this arm will receive 1000 mcg sublingual cyanocobalamin daily for 6 weeks. The supplement will be administered as a sublingual tablet placed under the tongue. Patients will continue their regular PPI therapy during the study period.
干预措施: Cyanocobalamin 1000 Mcg Sublingual Tablet (Drug)
Control Group (PPI Only)
Participants in this arm will continue their regular PPI therapy without receiving vitamin B12 supplementation. This arm serves as a control to evaluate natural changes in B12 levels without supplementation.
干预措施: Proton Pump Inhibitor therapy only (Other)
结局指标
主要结局
Change in Serum Vitamin B12 Concentration
时间窗: Baseline and Week 6
Measurement of serum vitamin B12 levels before and after 6 weeks of intervention to assess the efficacy of oral versus sublingual supplementation.
次要结局
- Change in Hemoglobin Level(Baseline and Week 6)
- Change in Plasma Homocysteine Level(Baseline and Week 6)
- Patient-Reported Satisfaction with Route of Supplementation(Week 6)
研究者
Reem Alaa Abdel Samie
teacher assistant in Delta University for science and technology
Tanta University