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Vitamin B12 Absorption Study

NCT07665671 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-07-22

No results posted yet for this 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.

Conditions

  • Healthy Volunteers

Interventions

DIETARY_SUPPLEMENT

Ampli-B

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

DIETARY_SUPPLEMENT

Vitamin B12

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

Sponsors & Collaborators

  • dsm-firmenich Switzerland AG

    collaborator INDUSTRY

  • RDC Clinical Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Alexandros Kanellopoulos · dsm-firmenich Switzerland AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07665671 on ClinicalTrials.gov