The Effect of Phentermine and B12 on Weight Loss Among Obese Patients
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Obesity Weight Loss |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | April 2013 |
A Pilot Study to Assess Whether the Combination of Phentermine and B12 Has a Significant Effect on Weight Loss Among an Obese Study Population
This is a pilot study designed to test the hypothesis that the combination of phentermine
and B12 will result in significantly greater weight loss among obese patients compared to
phentermine alone.
and B12 will result in significantly greater weight loss among obese patients compared to
phentermine alone.
This pilot study is a double blind, randomized controlled trial designed to determine the
significance of the combination therapy of phentermine and B12 injections among the obese
population. 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. Neither patients nor study team members will be aware of group
assignments through the entire duration of the study. Once randomized, both groups will
begin taking 37.5 mg/day orally of phentermine as well as receive weekly intramuscular
injections of either 1000 mg B12 or Saline depending on their group assignment. The study
will consist of approximately 15 visits over the course of 3 months.
significance of the combination therapy of phentermine and B12 injections among the obese
population. 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. Neither patients nor study team members will be aware of group
assignments through the entire duration of the study. Once randomized, both groups will
begin taking 37.5 mg/day orally of phentermine as well as receive weekly intramuscular
injections of either 1000 mg B12 or Saline depending on their group assignment. The study
will consist of approximately 15 visits over the course of 3 months.
Individuals can participate in the study if they meet the following inclusion criteria:
- 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)
- Are English speaking
Individuals should not participate in if any of the following apply to them:
- Are not over the age of 18
- Do not have a BMI between 30 and 40
- Do not have a controlled blood pressure
- Have a B12 deficiency
- Females who are pregnant, trying to get pregnant, or not willing to use a method of
birth control to ensure they do not become pregnant
- Individuals who do not speak English
- Individuals currently taking Adderall, Ritalin, or any other stimulant medication
- Individuals who have taken phentermine more than once in the past, or within 3 months
of study initiation
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