NCT00843453

Brief Summary

This study was designed to determine whether elderly residents of long term care facilitated who had been taking proton pump inhibitors (PPI) for more than 12 months were more likely to have vitamin B12 deficiency than residents not taking PPI, and whether cyanocobalamin nasal spray improved these subjects' vitamin B12 status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
Last Updated

July 23, 2009

Status Verified

July 1, 2009

Enrollment Period

1.2 years

First QC Date

February 12, 2009

Last Update Submit

July 21, 2009

Conditions

Vitamin B12 Deficiency

Keywords

vitamin B12 deficiencycyanocobalamin deficiencyproton pump inhibitorsomeprazole

Outcome Measures

Primary Outcomes (2)

  • serum vitamin B12

    baseline and after 8 weeks of treatment

  • serum methylmalonic acid (MMA)

    at baseline and after eight weeks of treatment

Study Arms (2)

1

OTHER

Comparison of serum vitamin and B12 concentrations of PPI and non-PPI groups

Other: blood collection

2

EXPERIMENTAL

Comparison of baseline and end of treatment serum vitamin B12 and MMA concentrations.

Drug: treatment (cyanocobalamin nasal spray)

Interventions

blood collectionOTHER

blood collection

Also known as: baseline
1
treatment (cyanocobalamin nasal spray)DRUG

cyanocobalamin nasal spray -- 500 mcg q week for eight weeks

2

Eligibility Criteria

Age60 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 60-89 years
  • PPI use for \>12 months (PPI group)
  • no PPI use for 30 days prior to arm 1
  • long term care resident

You may not qualify if:

  • pernicious anemia
  • severe megaloblastic anemia
  • free-living
  • serum creatinine \> 1.8 mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Long View Nursing Home

Manchester, Maryland, 21102, United States

Location

Stella Maris Nursing Home

Timonium, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Interventions

Blood Specimen CollectionBaseLine dental cementTherapeutics

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Nancy R Rozgony, RD< LD

    University of Delaware

    PRINCIPAL INVESTIGATOR

  • Chengshun R Fang, Ph.D.

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

November 1, 2006

Primary Completion

January 1, 2008

Study Completion

April 1, 2008

Last Updated

July 23, 2009

Record last verified: 2009-07

Locations

US(2)