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Vitamin B12 Absorption Study

24 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Tipo di studio

Interventistico

Iscrizione (Stimato)

12

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Queensland
      • Brisbane, Queensland, Australia
        • RDC Clinical
        • Investigatore principale:
          • David Briskey, PhD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • Vitamina B12
Comparatore attivo: Standard B12
Participants will receive a single capsule containing 1mg vitamin B12.
Participants will receive a single capsule containing 1mg vitamin B12 .
Altri nomi:
  • cobalamina

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Tmax of total vitamin b12 and holoTC between AmpliB and standard vitamin B12.
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 Cmax
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety: Incidence of post-emergent adverse events (AE)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Alexandros Kanellopoulos, dsm-firmenich Switzerland AG

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2026

Primo Inserito (Effettivo)

24 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Ampli-B

3
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