Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12).

It had two arms (groups): 1 (other) and 2 (experimental).

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

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

The registry classes the interventions as drug and other.

More on the Plan

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.

Who Took Part

The registry lists 36 actual participants took part.

It was open to people of any sex aged from 60 years up to 89 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could 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.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: pernicious anemia; severe megaloblastic anemia.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-11 with completion listed for 2008-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (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).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cyanocobalamin (Vitamin B12) in 36 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.