Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People

What Was Tested

In this phase 1 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

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

Placebo capsule, once per day.

Vitamin B12 and folic acid capsule, once a day.

The registry classes the interventions as dietary supplement.

More on the Plan

Rationale: There is growing evidence that an elevated homocysteine level is a risk factor for fracture incidence.

The most common cause of homocysteine elevation is poor vitamin B12 and folate status.

The intervention comprises a period of two years, and will be targeted to 3000 elderly subjects with elevated homocysteine levels.

Main study parameters/endpoints: Fracture incidence is the primary outcome measure Time to fracture will be calculated.

Who Took Part

3000 planned participants were the target.

It was open to people of any sex aged from 65 years with no upper age limit.

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

Examples of who could join: 65 years and older; based on entry date into study;. Fasting plasma Hcy level \>= 12 µmol/L and \< 50 µmol/L;. Competent to make own decisions;. Persons with skin cancer are allowed to participate.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: participation in other intervention trials;; immobilization (bedridden, wheelchair bound);.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-09 with completion listed for 2013-03.

It ran at 3 sites in Netherlands (3).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Fractures (time frame: two years).

It also tracked 5 secondary outcomes, for example Cognitive decline, Physical performance, Quality of life and Nutritional status.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cyanocobalamin (Vitamin B12) in 3000 people.

With 3000 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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