Study of the Ability of Betaine Hydrochloride to Increase Stomach Acid in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01237353
First received: November 5, 2010
Last updated: May 14, 2013
Last verified: May 2013
Results First Received: May 14, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pharmacodynamic
Interventions: Dietary Supplement: betaine hydrochloride
Drug: Rabeprazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy volunteers were recruited to one clinical site in the U.S.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Hypochlorhydria was induced through the administration of 20mg oral rabeprazole twice daily with food for four days prior to study day

Reporting Groups
  Description
Betaine Hydrochloride and Rabeprazole

betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5

Rabeprazole : rabeprazole po daily x 5 days


Participant Flow:   Overall Study
    Betaine Hydrochloride and Rabeprazole  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Betaine Hydrochloride and Rabeprazole

betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5

Rabeprazole : rabeprazole po daily x 5 days


Baseline Measures
    Betaine Hydrochloride and Rabeprazole  
Number of Participants  
[units: participants]
  6  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     0  
Age  
[units: years]
Mean ( Full Range )
  39.83  
  ( 25 to 57 )  
Gender  
[units: participants]
 
Female     2  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     6  



  Outcome Measures
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1.  Primary:   Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)   [ Time Frame: 30 minutes ]

2.  Secondary:   Duration of Gastric pH Status   [ Time Frame: 2 hours after dose of betaine HCl ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Leslie Benet
Organization: University of California San Francisco
phone: 415-476-3853
e-mail: leslie.benet@ucsf.edu


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01237353     History of Changes
Other Study ID Numbers: GastricpH-6264
Study First Received: November 5, 2010
Results First Received: May 14, 2013
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board