The Effect of Phentermine and B12 on Weight Loss Among Obese Patients
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|ClinicalTrials.gov Identifier: NCT01719185|
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : August 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obesity Hypertension||Drug: Phentermine and B12 Drug: Phentermine||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||April 2013|
Experimental: Phentermine and B12
Those in the experimental group will take 37.5 mg of phentermine daily as well as receive 1000 mg intramuscular injections of B12 weekly.
Drug: Phentermine and B12
Other Name: Adipex-P, Cyanocobalamin
Active Comparator: Phentermine
Those in the control group will take phentermine 37.5 mg daily as well as receive 1000 mg intramuscular injections of saline weekly.
Other Name: Adipex- P
- 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.
- 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.
- Waist Circumference [ Time Frame: 24 weeks ]Changes in waist circumference from baseline to 12 weeks and 24 weeks among the intervention and control groups.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719185
|United States, North Carolina|
|Brody Outpatient of Brody Medical Sciences Module D|
|Greenville, North Carolina, United States, 27834|
|Principal Investigator:||Michael C Lang, MD||ECU Physicians General Internal Medicine, Psychiatry|
|Study Chair:||James Powell, MD||ECU Physicians General Internal Medicine|