Vitamin B12 Acceptance and Biomarker Response Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vitamin B 12 Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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i.m. injection of Vitamin B12

Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks.

Group Type ACTIVE_COMPARATOR

i.m. injection of vitamin B12

Intervention Type DRUG

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

Oral administration of vitamin B12

High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring.

Group Type EXPERIMENTAL

Oral administration of vitamin B12

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

i.m. injection of vitamin B12

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

Intervention Type DRUG

Other Intervention Names

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Cyanocobolamin B12 "Ankermann" 1 mg Vitamin B12 intramuscular Cyanocobolamin Vitarubin Depot

Eligibility Criteria

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Inclusion Criteria

* General practitioner's prescription for Vitamin B12 deficiency testing
* Age\> 18 years
* Ability to give written informed consent
* Vitamin B12 serum concentrations \< 200pmol/l
* indication for vitamin B12 supplementation according to the General practitioners estimation

Exclusion Criteria

* Patients with incorrect intake of vitamin preparations containing vitamin B12
* Patients with previously diagnosed dementia
* Patients with known hereditary transcobalamin transportation defects
* lack of written and/or oral understanding in German, French, Italian or English languages

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No