Vitamin B12 DeficiencyNCT00843453
Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly
A study testing blood collection and treatment (cyanocobalamin nasal spray) in people with Vitamin B12 Deficiency, run by University of Delaware at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin B12 Deficiency
- What is being tested?
- blood collection and treatment (cyanocobalamin nasal spray)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2006to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pernicious anemia
- severe megaloblastic anemia
- free-living
- serum creatinine > 1.8 mg/dL
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Long View Nursing Home
Manchester, Maryland, 21102
Stella Maris Nursing Home
Timonium, Maryland, 21093
About this study
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.
Read the detailed description
Subjects had serum creatinine <1.8 mg/dL, no diagnosis of severe megaloblastic or pernicious anemia, and had not been taking vitamin B12 supplements. At baseline, serum vitamin B12 and methylmalonic acid (MMA) concentrations of 34 subjects from the PPI group were compared with those of the non-PPI group. The PPI group (n=13) was treated with cyanocobalamin nasal spray for eight weeks, and post-treatment vitamin B12 and MMA concentrations were compared with baseline concentrations.
- Conditions
- Vitamin B12 Deficiency
- Being tested
- blood collection, treatment (cyanocobalamin nasal spray)
- Keywords
- vitamin B12 deficiency, cyanocobalamin deficiency, proton pump inhibitors, omeprazole
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collectionOther
Also called baseline
blood collection
treatment (cyanocobalamin nasal spray)Drug
cyanocobalamin nasal spray -- 500 mcg q week for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Comparison of serum vitamin and B12 concentrations of PPI and non-PPI groups Receives: Other: blood collection |
| 2 | Experimental | Comparison of baseline and end of treatment serum vitamin B12 and MMA concentrations. Receives: Drug: treatment (cyanocobalamin nasal spray) |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum vitamin B12
Measured: baseline and after 8 weeks of treatment
serum methylmalonic acid (MMA)
Measured: at baseline and after eight weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startNov 2006
- Primary completionJan 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin B12 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Investigators
- Nancy R Rozgony, RD< LD, Principal investigator, University of DelawareChengshun R Fang, Ph.D., Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843453
- Sponsor's protocol ID
- HS08-165
- Status last verified
- Jul 2009
- First submitted
- 12 Feb 2009
- Last updated
- 23 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly
- ClinicalTrials.gov ID
- NCT00843453
- Acronym / sponsor ID
- HS08-165
- Conditions
- Vitamin B12 Deficiency
- Keywords
- vitamin B12 deficiency, cyanocobalamin deficiency, proton pump inhibitors, omeprazole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects had serum creatinine <1.8 mg/dL, no diagnosis of severe megaloblastic or pernicious anemia, and had not been taking vitamin B12 supplements. At baseline, serum vitamin B12 and methylmalonic acid (MMA) concentrations of 34 subjects from the PPI group were compared with those of the non-PPI group. The PPI group (n=13) was treated with cyanocobalamin nasal spray for eight weeks, and post-treatment vitamin B12 and MMA concentrations were compared with baseline concentrations.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: blood collectionComparison of serum vitamin and B12 concentrations of PPI and non-PPI groups |
| 2 | Experimental | Drug: treatment (cyanocobalamin nasal spray)Comparison of baseline and end of treatment serum vitamin B12 and MMA concentrations. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- pernicious anemia
- severe megaloblastic anemia
- free-living
- serum creatinine > 1.8 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood collectionAlso: baselineblood collection | Other | 1 |
| treatment (cyanocobalamin nasal spray)cyanocobalamin nasal spray -- 500 mcg q week for eight weeks | Drug | 2 |
Primary outcome
serum vitamin B12
Time frame: baseline and after 8 weeks of treatment
serum methylmalonic acid (MMA)
Time frame: at baseline and after eight weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy R Rozgony, RD< LD principal investigator
University of Delaware
Chengshun R Fang, Ph.D. principal investigator
University of Delaware
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood collection and treatment (cyanocobalamin nasal spray) in people with Vitamin B12 Deficiency, run by University of Delaware at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum vitamin B12 (time frame: baseline and after 8 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2009.