Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

B6 Treatment for Nausea and Vomiting in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763633
Recruitment Status : Unknown
Verified September 2008 by Showa University.
Recruitment status was:  Recruiting
First Posted : October 1, 2008
Last Update Posted : December 31, 2008
Sponsor:
Collaborator:
University of Bologna
Information provided by:
Showa University

Tracking Information
First Submitted Date  ICMJE September 29, 2008
First Posted Date  ICMJE October 1, 2008
Last Update Posted Date December 31, 2008
Study Start Date  ICMJE January 2008
Estimated Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
Nausea and vomiting score [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
Vitamin B6 concentration in nausea and vomiting of pregnancy [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE B6 Treatment for Nausea and Vomiting in Pregnancy
Official Title  ICMJE Vitamin B6 Concentration and Treatment in Nausea and Vomiting of Pregnancy
Brief Summary The purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is effective in nausea and vomiting of pregnancy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Nausea and Vomiting Complain in Early Pregnancy
Intervention  ICMJE
  • Drug: vitamin B6
    high dose of vitamin B6
  • Drug: vitamin B6
    low vitamin B6
Study Arms  ICMJE
  • Active Comparator: highB6
    high vitamin B6
    Intervention: Drug: vitamin B6
  • Active Comparator: lowB6
    low vitamin B6
    Intervention: Drug: vitamin B6
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 29, 2008)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2008
Estimated Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Nausea and vomiting of pregnancy

Exclusion Criteria:

  • Other medical condition causing nausea and vomiting of pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00763633
Other Study ID Numbers  ICMJE B601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dept. Obstetrics Gynecology Fac. Medicine Univ. Indonesia, Univ. Indonesia
Study Sponsor  ICMJE Showa University
Collaborators  ICMJE University of Bologna
Investigators  ICMJE
Principal Investigator: Noroyono Wibowo, MD, PhD Dept. Obstetric Gynecology Univ. Indonesia
PRS Account Showa University
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP