NCT01832129

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

2.6 years

First QC Date

April 5, 2013

Last Update Submit

June 12, 2016

Conditions

Vitamin B 12 Deficiency

Outcome Measures

Primary Outcomes (1)

  • Biochemical response to vitamin B12 substitution

    Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)

    Day 28

Secondary Outcomes (2)

  • taking and timing adherence with oral vitamin B12

    day 28

  • Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation

    day 0, day 28

Study Arms (2)

i.m. injection of Vitamin B12

ACTIVE COMPARATOR

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

Drug: i.m. injection of vitamin B12

Oral administration of vitamin B12

EXPERIMENTAL

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

Drug: Oral administration of vitamin B12

Interventions

Oral administration of vitamin B12DRUG

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.

Also known as: Cyanocobolamin, B12 "Ankermann" 1 mg
Oral administration of vitamin B12
i.m. injection of vitamin B12DRUG

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

Also known as: Vitamin B12 intramuscular, Cyanocobolamin, Vitarubin Depot
i.m. injection of Vitamin B12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmaceutical Care Research Group

Basel, Basel, CH-4056, Switzerland

Location

Related Publications (1)

  • Metaxas C, Mathis D, Jeger C, Hersberger KE, Arnet I, Walter P. Early biomarker response and patient preferences to oral and intramuscular vitamin B12 substitution in primary care: a randomised parallel-group trial. Swiss Med Wkly. 2017 Apr 7;147:w14421. doi: 10.4414/smw.2017.14421. eCollection 2017.

    PMID: 28421567DERIVED

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Kurt E Hersberger, Professor

    Pharmaceutical Care Research Group

    STUDY CHAIR

  • Cyrill Jeger, MD

    PRINCIPAL INVESTIGATOR

  • Philipp N Walter, MSc

    Pharmaceutical Care Research Group

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 15, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

CH(1)