We updated the design of this site on December 18, 2017. Learn more.
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

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.

Condition or disease Intervention/treatment Phase
Nausea and Vomiting Complain in Early Pregnancy Drug: vitamin B6 Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Vitamin B6 Concentration and Treatment in Nausea and Vomiting of Pregnancy
Study Start Date : January 2008
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: highB6
high vitamin B6
Drug: vitamin B6
high dose of vitamin B6
Active Comparator: lowB6
low vitamin B6
Drug: vitamin B6
low vitamin B6



Primary Outcome Measures :
  1. Nausea and vomiting score [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Vitamin B6 concentration in nausea and vomiting of pregnancy [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nausea and vomiting of pregnancy

Exclusion Criteria:

  • Other medical condition causing nausea and vomiting of pregnancy

Information from the National Library of Medicine

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): NCT00763633


Contacts
Contact: Noroyono Wibowo, MD, PhD +6221 3915041 wibowonoroyono@yahoo.com
Contact: Yuditiya Purwosunu, MD +6221 3915041 yudi@med.showa-u.ac.jp

Locations
Indonesia
Dept. Obstetric Gynecology Univ. Indonesia Recruiting
Jakarta, Indonesia, 13210
Contact: Noroyono Wibowo, MD, PhD    +6221 3915041    wibowonoroyono@yahoo.com   
Principal Investigator: Noroyono Wibowo, MD, PhD         
Sub-Investigator: Yuditiya Purwosunu, MD         
Sponsors and Collaborators
Showa University
University of Bologna
Investigators
Principal Investigator: Noroyono Wibowo, MD, PhD Dept. Obstetric Gynecology Univ. Indonesia

Additional Information:
Responsible Party: Dept. Obstetrics Gynecology Fac. Medicine Univ. Indonesia, Univ. Indonesia
ClinicalTrials.gov Identifier: NCT00763633     History of Changes
Other Study ID Numbers: B601
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: September 2008

Keywords provided by Showa University:
nausea
vomiting
pregnancy
B6

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Vitamins
Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs