NCT07665671已完成4 期
A Randomized, Double-Blind, Cross-Over Clinical Trial to Compare the Absorption of Different Forms of Vitamin B12 (AMPLIB12)
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Tmax of total vitamin b12 and holoTC between AmpliB and standard vitamin B12.
研究概览
简要总结
This randomized, double-blind, crossover trial (Phase IV) aims to compare the absorption of a novel permeability-enhanced oral vitamin B12 formulation (Ampli-B) versus standard oral vitamin B12 in 12 healthy adults aged 50 years and older. Each participant receives a single dose of each formulation in randomized sequence, separated by a minimum 10-day washout. The primary outcome is time to peak serum concentration (Tmax) of total and active vitamin B12 (holotranscobalamin). Secondary outcomes include Cmax and AUC parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 50 years of age and older
- •BMI between 18 to 29.9 kg/m2
- •Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- •Woman of child-bearing potential (WOCBP) must be following appropriate contraceptive methods until the last visit:
- •Sexual abstinence.
- •Oral contraceptive.
- •Trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration).
- •Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration).
- •Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
- •Contraceptives must be effective before product administration.
- •Agrees not to take any vitamin B12 containing supplements until the completion of the study.
- •Agrees to avoid consuming liver, kidney, organ meats and very high B12 containing shellfish (e.g. clams and crab) 72 hours prior to study visits
- •Agrees to consume the standardized meals for each of the study visits
- •Agrees to avoid alcohol intake 48 hours prior to study visits
- •Agrees to maintain current lifestyle habits (physical activity, medications, supplements, and sleep) as much as possible throughout the study
- •Able to fast for 10 hours prior to study visits (visit 1 and visit 3)
- •Provided voluntary, written, informed consent to participate in the study
排除标准
- •Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- •Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational products
- •History or current diagnosis of any clinically significant disease that may alter vitamin B12 absorption, accumulation, metabolism or excretion
- •Taking vitamin B12 supplements or a multivitamin supplement containing vitamin B12 within the prior 2 months from study product administration.
- •Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the absorption of vitamin B12
- •Have a serious illness e.g. mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, diabetes, liver disease, autoimmune disease, bleeding disorders or heart conditions
- •Have an unstable illness e.g. diabetes and thyroid gland dysfunction
- •Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- •Gastrointestinal or absorption issues (IBD, IBS, Celiac disease, Crohn's disease, history of GI surgery, Small Intestinal Bacterial Overgrowth)
- •Poor venous access
- •Current use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- •Active smokers, nicotine use or drug (prescription or illegal substances) abuse.
- •Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Blood donation 60 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- •Participation in other clinical research studies 30 days prior to baseline, as assessed by the PI
- •Any other condition or lifestyle factor, that, in the opinion of the PI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
研究组 & 干预措施
Standard B12
Active Comparator
Participants will receive a single capsule containing 1mg vitamin B12.
干预措施: Vitamin B12 (Dietary Supplement)
Ampli-B
Experimental
Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.
干预措施: Ampli-B (Dietary Supplement)
结局指标
主要结局
Tmax of total vitamin b12 and holoTC between AmpliB and standard vitamin B12.
时间窗: Day 1 to 24hrs post Visit 3 (visit 4/day 11)
Comparison of the time to peak maximum concentration (tmax) of total serum cyanocobalamin (total vitamin B12) and active cyanocobalamin \[holotranscobalamin (holoTC)\] between AmpliB and standard vitamin B12.
次要结局
- Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 Cmax(Baseline to 24hours post visit 3 (visit 4/day 11))
- Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 area under the concentration-time curve from 0h to 24hr(Baseline to 24hours post visit 3 (visit 4/day 11))
- Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 area under the concentration-time curve from 0 h to infinity(Baseline to 24hours post visit 3 (visit 4/day 11))
- Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal disposition rate constant(Baseline to 24hours post visit 3 (visit 4/day 11))
- Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal half-life(Baseline to 24hours post visit 3 (visit 4/day 11))
- Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin Cmax(Baseline to 24hours post visit 3 (visit 4/day 11))
- Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin area under the concentration-time curve from 0 h to 24h(Baseline to 24hours post visit 3 (visit 4/day 11))
- Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin area under the concentration-time curve from 0 h to infinity(Baseline to 24hours post visit 3 (visit 4/day 11))
- Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin terminal disposition rate constant(Baseline to 24hours post visit 3 (visit 4/day 11))
- Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin terminal half-life(Baseline to 24hours post visit 3 (visit 4/day 11))
研究者
研究点 (2)
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