NCT01312831已完成不适用
A 60-DAY, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Eligen® B12 OR Intramuscularly Administered B12 in Subjects With Low Serum Cobalamin With a 30 Day Extension to 90 Days of Dosing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Serum Cobalamin Normalization
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety profile of a new oral vitamin B12 formulation (Eligen® B12) with intramuscular B12 in restoring normal B12 (cobalamin) concentrations in subjects with low cobalamin levels (<350 pg/mL).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vitamin B12 deficiency defined as serum cobalamin below 350 pg/mL
- •Age 60 or older; or age 18 or older with gastrointestinal abnormalities including but not limited to gastrointestinal surgery (e.g. gastrectomy, gastric bypass), ileal resection, gastric atrophy, Celiac disease, Crohn's disease, or prolonged use (>3 months) of proton pump inhibitor drugs, or on a restricted diet (such as vegetarian or vegan).
- •General good health, as indicated by lack of significant findings in medical history, physical examination, clinical laboratory tests (chemistry, hematology and urinalysis), vital signs, ECG and normal kidney function as determined by estimated creatinine clearance computed with the Cockcroft and Gault formula
排除标准
- •Current treatment from a health care provider to treat vitamin B12 deficiency and/or symptoms;
- •Daily use of neutralizing antacids (e.g. Maalox®)
- •Inability to ingest oral medication
- •Clinically significant laboratory value at screening
- •Hypersensitivity or allergic reaction to vitamin B12
- •Participation in a clinical research study involving a new chemical entity within 30 days of the first study dose
- •Folate levels below the reference range provided by the clinical laboratory.
- •Renal insufficiency
- •Vitamin B6 deficiency
结局指标
主要结局
Serum Cobalamin Normalization
时间窗: 61 days
The primary efficacy outcome compares the proportion of subjects in each treatment arm in whom cobalamin levels are normalized (i.e., cobalamin ≥ 350 ng/mL) following 60 days of treatment
次要结局
- Maintenance of B12 Normalization(91 days)
- Time to Normalization(90 days)
- Percent Change from Baseline in Cobalamin Levels After 60 and 90 days of Treatment(91 days)
- Percent Change from Baseline in Methylmalonic Acid (MMA) Levels After 60 and 90 Days of Treatment(91 days)
- Percent Change from Baseline in Homocysteine Levels After 60 and 90 Days of Treatment(91 days)
- Number of Subjects with Adverse Events as a Measure of Safety and Tolerability(91 days)
- Holo-trancobalamin (holo-TC) Normalization(91 days)
- Holo-TC and Cobalamin Correlation(91 days)
研究者
相似试验
已完成
不适用
Vitamin B12 Biomarker Responses to SupplementationHealthyNCT04731948University of Ulster200
终止
2 期
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal TransplantationKidney TransplantationNCT06365437ITB-Med LLC33
已完成
2 期
A Dose Escalation Study in de Novo Renal TransplantationKidney TransplantationNCT04311632ITB-Med LLC13
已完成
不适用
Multi-center randomized controlled trial to evaluate oral vitamin B12 treatment for vitamin B12 deficiency after total gastrectomy in gastric cancer patientsgastric cancerJPRN-jRCTs031180231Rino Yasushi78
撤回
3 期
Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)Relapsing-Remitting Multiple SclerosisRelapsing Forms of Multiple SclerosisNCT02428218Biogen