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Completed

NCT Number: NCT01719185

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Brody Outpatient of Brody Medical Sciences Module D

Greenville, North Carolina, 27834, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phentermine and B12

Drug

Other names: Adipex-P, Cyanocobalamin

Phentermine

Drug

Other names: Adipex- P

Primary outcomes

  1. Weight Change

    Time frame: 24 weeks (6 months)

    Weight change from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention (phentermine and B12) and control (phentermine) groups.

Secondary outcomes

  1. Blood Pressure

    Time frame: 24 weeks

    Blood pressure changes from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention and control groups.

  2. Waist Circumference

    Time frame: 24 weeks

    Changes in waist circumference from baseline to 12 weeks and 24 weeks among the intervention and control groups.

  3. Waist to hip ratio

    Time frame: 24 weeks

    Changes in waist to hip ratio from baseline to 12 weeks and 24 weeks among the intervention and control group.

Sponsors and collaborators

Lead sponsor

Dr. Michael Lang

Other

Registry information

Official study title

A Pilot Study to Assess Whether the Combination of Phentermine and B12 Has a Significant Effect on Weight Loss Among an Obese Study Population

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 1, 2012
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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