B6 Treatment for Nausea and Vomiting in Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Showa University.
Recruitment status was  Recruiting
University of Bologna
Information provided by:
Showa University
ClinicalTrials.gov Identifier:
First received: September 29, 2008
Last updated: December 30, 2008
Last verified: September 2008
The purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is effective in nausea and vomiting of pregnancy.

Condition Intervention Phase
Nausea and Vomiting Complain in Early Pregnancy
Drug: vitamin B6
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Vitamin B6 Concentration and Treatment in Nausea and Vomiting of Pregnancy

Resource links provided by NLM:

Further study details as provided by Showa University:

Primary Outcome Measures:
  • Nausea and vomiting score [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Vitamin B6 concentration in nausea and vomiting of pregnancy [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2008
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Nausea and vomiting of pregnancy

Exclusion Criteria:

  • Other medical condition causing nausea and vomiting of pregnancy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763633

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

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
Principal Investigator: Noroyono Wibowo, MD, PhD Dept. Obstetric Gynecology Univ. Indonesia
  More Information

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 
Study First Received: September 29, 2008
Last Updated: December 30, 2008
Health Authority: Indonesia: Departement Kesehatan (Department of Health)

Keywords provided by Showa University:

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Vitamin B 6
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016