Is long-term PPI-use associated with low vitamin B12 levels in old age?
ID
Source
Brief title
Condition
- Vitamin related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will compare serum vitamin B12, folic acid and homocysteine between the two
study groups.
Results will be adjusted for possible differences in nutritional behavior and
status, health status, use of vitamin supplements and helicobacter pylori
status.
Secondary outcome
We will compare hemoglobin levels and mean corpuscular volumebetween the two
study groups.
Background summary
Many elderly individuals use proton pump inhibitors (PPIs) for
gastro-esophageal reflux disease (GERD), peptic ulcer and chronic use of
NSAIDS. However, PPIs inhibit the formation of gastric acid in the stomach.
Gastric acid is essential for the release of vitamin B12 from food. Long-term
PPI-use might therefore lead to vitamin B12 deficiency in the elderly.
Study objective
Is long-term PPI-use associated with low vitamin B12 levels in old age?
Study design
Blood parameters will be compared between long-term PPI-users (> 3 years) of 65
years and older (N=110) and their partners (N=110).
Study burden and risks
Burden: PPI-users and partners visit the lab or are visited by a trained
employee from the lab. 6 mL blood is drawn from every participant.
Additionally, every participant is asked to fill in a short questionnaire on
nutritional status, use of medication (incl. vitamin supplements), and other
demographic characteristics.
Risk: The collection of small blood samples is standard procedure in medical
practice. The risk of study participation is therefore small.
Benefit: The general practitioner will be informed on the lab results. In case
of abnormal lab values, the general practitioner might initiate treatment.
Postbus 2088
2301 CB Leiden
Nederland
Postbus 2088
2301 CB Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Individuals of 65 years and older that have had at least 810 Defined Daily Doses (DDD) of proton pump inhibitors in the last three years and live with their partner.
Exclusion criteria
A couple will be excluded from study participation if the general practitioner indicates that one of the following characteristics apply to the user of proton pump inhibitors or partner:
-vitamin B12 supplementation
-folic acid supplementation
-use of H2-blockers
-use of antacids
-known chronic alcohol abuse
-cognitive impairment
A couple will also be excluded when the partner uses proton pump inhibitors.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11916.058.06 |