Vitamin B12 Absorption Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Ampli-B; Dietary supplement: Vitamin B12

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: David Briskey; Phone Number: +61(0)731024486; Email: research@rdcglobal.com.au

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia
      • RDC Clinical
      • Principal Investigator: David Briskey, PhD
      • Contact: David Briskey; Phone Number: +61 (0) 731024486; Email: research@rdcglobal.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ampli-B; Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.	Dietary supplement: Ampli-B; Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.; Other Names: Vitamin B12
Active Comparator: Standard B12; Participants will receive a single capsule containing 1mg vitamin B12.	Dietary supplement: Vitamin B12; Participants will receive a single capsule containing 1mg vitamin B12 .; Other Names: cobalamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 to 24hrs post Visit 3 (visit 4/day 11)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	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	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	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	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	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	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	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	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Incidence of post-emergent adverse events (AE)	Incidence of post-emergent adverse events (AE)	Baseline to 24hours post visit 3 (visit 4/day 11)
Safety: Changes in vital signs (blood pressure)	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)	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	Clinically relevant changes in FBC after supplementation.	Baseline to 24hours post visit 3 (visit 4/day 11)
Safety: Changes in E/LFT	Clinically relevant changes in E/LFT after supplementation.	Baseline to 24hours post visit 3 (visit 4/day 11)

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Collaborators: dsm-firmenich Switzerland AG
• Investigators: Study Director: Alexandros Kanellopoulos, dsm-firmenich Switzerland AG

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: 50 years and older
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Azoles; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Pyrroles; Macrocyclic Compounds; Tetrapyrroles; Corrinoids; Vitamin B 12
• Other Study ID Numbers: 2024-06-28-AMPLIB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No