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Vitamin B12 Acceptance and Biomarker Response Study

NCT01832129 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-06-14

No results posted yet for this study

Summary

In this study, biomarker response after supplementation with oral and intramuscular vitamin B12 will be compared in a randomized clinical trial. Electronic compliance monitoring will be used to control for non compliance as a possible confounder in oral treatment. Additionally subjective acceptance in terms of presumed preferences will be compared with oral vs. intramuscular supplementation of vitamin B12 in the view of the patient.

Conditions

  • Vitamin B 12 Deficiency

Interventions

DRUG

Oral administration of vitamin B12

Daily high dose oral vitamin B12 (1mg) will be administered over 4 weeks. The patients adherence to this regimen will be monitored with an electronic punch card.

DRUG

i.m. injection of vitamin B12

Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21.

Sponsors & Collaborators

  • University of Basel

    collaborator OTHER

  • Aarelab AG

    collaborator INDUSTRY

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Kurt E Hersberger, Professor · Pharmaceutical Care Research Group

  • Cyrill Jeger, MD

  • Philipp N Walter, MSc · Pharmaceutical Care Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Switzerland

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 NCT01832129 on ClinicalTrials.gov