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B6 Treatment for Nausea and Vomiting in Pregnancy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by Showa University.
Recruitment status was:  Recruiting
University of Bologna
Information provided by:
Showa University 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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
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 ]

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

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   (Child, Adult)
Sexes 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
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Please refer to this study by its identifier: NCT00763633

Contact: Noroyono Wibowo, MD, PhD +6221 3915041
Contact: Yuditiya Purwosunu, MD +6221 3915041

Dept. Obstetric Gynecology Univ. Indonesia Recruiting
Jakarta, Indonesia, 13210
Contact: Noroyono Wibowo, MD, PhD    +6221 3915041   
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 Identifier: NCT00763633     History of Changes
Other Study ID Numbers: B601
Study First Received: September 29, 2008
Last Updated: December 30, 2008

Keywords provided by Showa University:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Vitamin B 6
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on May 25, 2017