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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
Sponsor:
Collaborator:
University of Bologna
Information provided by:
Showa University
ClinicalTrials.gov Identifier:
NCT00763633
First received: September 29, 2008
Last updated: December 30, 2008
Last verified: September 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Univ. Indonesia web-link  This link exits the ClinicalTrials.gov site

No publications provided

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:
nausea
vomiting
pregnancy
B6

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

ClinicalTrials.gov processed this record on May 19, 2013