The Effect of Phentermine and B12 on Weight Loss Among Obese Patients

What Was Tested

This registered early phase 1 trial tested Cyanocobalamin (Vitamin B12) for fat loss, obesity & body recomposition.

It had two arms (groups): Phentermine and B12 (experimental) and Phentermine (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study population will be recruited from the ECU Physicians Internal Medicine clinic.

Physicians will select patients meeting inclusion and exclusion criteria from their clinic to be approached for recruitment.

Approximately 30 patients will be recruited and blindly randomized to either the treatment group (phentermine and B12 in combination) or the control group (phentermine alone).

Patients will be randomized by means of block randomization in a 1:1 ratio.

Who Took Part

The registry lists 22 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Are over the age of 18. Have a BMI between 30 and 40. Have a controlled blood pressure. Do not have a B12 deficiency. Are willing to take birth control (if female and not sterile or through menopause).

The full record lists 14 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The fat loss, obesity & body recomposition participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

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

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

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

It started in 2012-09 with completion listed for 2013-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Weight Change (time frame: 24 weeks (6 months)).

It also tracked 3 secondary outcomes, for example Blood Pressure, Waist Circumference and Waist to hip ratio.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Cyanocobalamin (Vitamin B12) in 22 people with fat loss, obesity & body recomposition.

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, Fat loss, obesity & body recomposition research.