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Vitamin B12 Absorption Study

2026년 6월 24일 업데이트: RDC Clinical Pty Ltd

A Randomized, Double-Blind, Cross-Over Clinical Trial to Compare the Absorption of Different Forms of Vitamin B12 (AMPLIB12)

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.

연구 개요

연구 유형

중재적

등록 (추정된)

12

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Queensland
      • Brisbane, Queensland, 호주
        • RDC Clinical
        • 수석 연구원:
          • David Briskey, PhD
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

설명

Inclusion Criteria:

  1. Males and females 50 years of age and older
  2. BMI between 18 to 29.9 kg/m2
  3. 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.
  4. Agrees not to take any vitamin B12 containing supplements until the completion of the study.
  5. 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
  6. Agrees to consume the standardized meals for each of the study visits
  7. Agrees to avoid alcohol intake 48 hours prior to study visits
  8. Agrees to maintain current lifestyle habits (physical activity, medications, supplements, and sleep) as much as possible throughout the study
  9. Able to fast for 10 hours prior to study visits
  10. Provided voluntary, written, informed consent to participate in the study

Exclusion Criteria:

  1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
  2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational products
  3. History or current diagnosis of any clinically significant disease that may alter vitamin B12 absorption, accumulation, metabolism or excretion
  4. Taking vitamin B12 supplements or a multivitamin supplement containing vitamin B12 within the prior 2 months from study product administration.
  5. 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
  6. 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
  7. Have an unstable illness e.g. diabetes and thyroid gland dysfunction
  8. Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
  9. Gastrointestinal or absorption issues (IBD, IBS, Celiac disease, Crohn's disease, history of GI surgery, Small Intestinal Bacterial Overgrowth)
  10. Poor venous access
  11. Current use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
  12. Active smokers, nicotine use or drug (prescription or illegal substances) abuse.
  13. Chronic past and/or current alcohol use (>14 alcoholic drinks week)
  14. Blood donation 60 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
  15. Participation in other clinical research studies 30 days prior to baseline, as assessed by the PI
  16. 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Ampli-B
Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.
Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.
다른 이름들:
  • 비타민 B12
활성 비교기: Standard B12
Participants will receive a single capsule containing 1mg vitamin B12.
Participants will receive a single capsule containing 1mg vitamin B12 .
다른 이름들:
  • 코발라민

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Tmax of total vitamin b12 and holoTC between AmpliB and standard vitamin B12.
기간: 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.
Day 1 to 24hrs post Visit 3 (visit 4/day 11)

2차 결과 측정

결과 측정
측정값 설명
기간
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 Cmax
기간: Baseline to 24hours post visit 3 (visit 4/day 11)

Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:

• The maximum concentration (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
기간: Baseline to 24hours post visit 3 (visit 4/day 11)

Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:

• The area under the concentration-time curve from 0 h to time of last measured concentration (AUC0-24h)

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
기간: Baseline to 24hours post visit 3 (visit 4/day 11)

Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:

• The area under the concentration-time curve from 0 h to infinity (AUC0-∞)

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
기간: Baseline to 24hours post visit 3 (visit 4/day 11)

Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:

• The terminal disposition rate constant (λ)

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
기간: Baseline to 24hours post visit 3 (visit 4/day 11)

Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:

• The terminal half-life (t½)

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
기간: 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 pharmacokinetic parameters:

• 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
기간: 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 pharmacokinetic parameters:

• The area under the concentration-time curve from 0 h to time of last measured concentration (AUC0-24h)

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
기간: 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 pharmacokinetic parameters:

• The area under the concentration-time curve from 0 h to infinity (AUC0-∞)

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
기간: 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 pharmacokinetic parameters:

• The terminal disposition rate constant (λ)

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
기간: 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 pharmacokinetic parameters:

• The terminal half-life (t½)

Baseline to 24hours post visit 3 (visit 4/day 11)

기타 결과 측정

결과 측정
측정값 설명
기간
Safety: Incidence of post-emergent adverse events (AE)
기간: Baseline to 24hours post visit 3 (visit 4/day 11)
Incidence of post-emergent adverse events (AE)
Baseline to 24hours post visit 3 (visit 4/day 11)
Safety: Changes in vital signs (blood pressure)
기간: Baseline to 24hours post visit 3 (visit 4/day 11)
Clinically relevant changes in vital signs blood pressure (BP) after acute supplementation
Baseline to 24hours post visit 3 (visit 4/day 11)
Safety: Changes in vital signs (heart rate)
기간: Baseline to 24hours post visit 3 (visit 4/day 11)
Clinically relevant changes in vital signs heart rate after acute supplementation
Baseline to 24hours post visit 3 (visit 4/day 11)
Safety: Changes in FBC
기간: Baseline to 24hours post visit 3 (visit 4/day 11)
Clinically relevant changes in FBC after supplementation.
Baseline to 24hours post visit 3 (visit 4/day 11)
Safety: Changes in E/LFT
기간: Baseline to 24hours post visit 3 (visit 4/day 11)
Clinically relevant changes in E/LFT after supplementation.
Baseline to 24hours post visit 3 (visit 4/day 11)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Alexandros Kanellopoulos, dsm-firmenich Switzerland AG

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 6월 18일

QC 기준을 충족하는 최초 제출

2026년 6월 18일

처음 게시됨 (실제)

2026년 6월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 24일

마지막으로 확인됨

2026년 6월 1일

추가 정보

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Ampli-B에 대한 임상 시험

3
구독하다