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CompletedNCT07665671Updated Sep 9, 2026

Vitamin B12 Absorption Study

A Phase 4 interventional study of Ampli-B and Vitamin B12 in Healthy Volunteers, sponsored by RDC Clinical Pty Ltd. Completed at 1 site in Australia. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by RDC Clinical Pty Ltd · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • 50 years and older
03

In context

Lead sponsor

RDC Clinical Pty Ltd is the lead sponsor of 34 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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 (visit 1 and visit 3)
  10. Provided voluntary, written, informed consent to participate in the study

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Ampli-B

    Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.

    Dietary Supplement: Ampli-B

  • Active comparator
    Standard B12

    Participants will receive a single capsule containing 1mg vitamin B12.

    Dietary Supplement: Vitamin B12

Interventions

  • Dietary supplementAmpli-B

    Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.

    Also known as: Vitamin B12

  • Dietary supplementVitamin B12

    Participants will receive a single capsule containing 1mg vitamin B12 .

    Also known as: cobalamin

06

What researchers measure

Primary outcomes

  1. Tmax of total vitamin b12 and holoTC between AmpliB and standard vitamin B12.

    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.

    Time frame: Day 1 to 24hrs post Visit 3 (visit 4/day 11)

Secondary outcomes

  1. Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 Cmax

    Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters: • The maximum concentration (Cmax)

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

  2. Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 area under the concentration-time curve from 0h to 24hr

    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)

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

  3. 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

    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-∞)

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

  4. Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal disposition rate constant

    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)

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

  5. Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal half-life

    Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters: • The terminal half-life (t½)

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

  6. Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin Cmax

    Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin pharmacokinetic parameters: • Cmax

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

  7. 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

    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)

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

  8. 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

    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-∞)

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

  9. Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin terminal disposition rate constant

    Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin pharmacokinetic parameters: • The terminal disposition rate constant (λ)

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

  10. Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin terminal half-life

    Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin pharmacokinetic parameters: • The terminal half-life (t½)

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

Other outcomes

  1. Safety: Incidence of post-emergent adverse events (AE)

    Incidence of post-emergent adverse events (AE)

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

  2. Safety: Changes in vital signs (blood pressure)

    Clinically relevant changes in vital signs blood pressure (BP) after acute supplementation

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

  3. Safety: Changes in vital signs (heart rate)

    Clinically relevant changes in vital signs heart rate after acute supplementation

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

  4. Safety: Changes in FBC

    Clinically relevant changes in FBC after supplementation.

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

  5. Safety: Changes in E/LFT

    Clinically relevant changes in E/LFT after supplementation.

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

07

Study locations

1 site
  • RDC Clinical
    Brisbane, Queensland, Australia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07665671
Lead sponsor
RDC Clinical Pty Ltd
Collaborators
dsm-firmenich Switzerland AG
Responsible party
Sponsor
First posted
Jun 24, 2026
Start date
Jul 20, 2026
Primary completion
Aug 21, 2026
Completion
Aug 21, 2026
Last update
Sep 9, 2026

Study contacts

Alexandros Kanellopoulos
study director · dsm-firmenich Switzerland AG

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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