Vitamin B12 Absorption Study

NCT07665671 | Recruiting Phase 4

• 1 other identifier: 2024-06-28-AMPLIB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

50 years and older

Outcome Measures

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.

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

Secondary Outcomes (10)

• 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)

Other Outcomes (5)

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

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

• Safety: Changes in vital signs (blood pressure)

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

• Safety: Changes in vital signs (heart rate)

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

Study Arms (2)

Ampli-B

EXPERIMENTAL

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

Dietary Supplement: Ampli-B

Standard B12

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin B12

Interventions

Ampli-B DIETARY_SUPPLEMENT

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

Also known as: Vitamin B12

Ampli-B

Vitamin B12 DIETARY_SUPPLEMENT

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

Also known as: cobalamin

Standard B12

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead
• dsm-firmenich Switzerland AG: collaborator

Study Sites (1)

RDC Clinical

Brisbane, Queensland, Australia

RECRUITING

MeSH Terms

Interventions

Vitamin B 12

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Alexandros Kanellopoulos

  dsm-firmenich Switzerland AG

  STUDY DIRECTOR

Central Study Contacts

David Briskey

CONTACT

+61(0)731024486; research@rdcglobal.com.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-06

Locations

AU (1)