Other Clinical Trial - B6 Treatment for Nausea & Vomiting NCT00763633

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Unknown status

The purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is effective in nausea and vomiting of pregnancy.

Recruitment information / eligibility
Status	Unknown status
Enrollment	150
Est. completion date	October 2008
Est. primary completion date	October 2008
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Female
Age group	15 Years to 40 Years
Eligibility	Inclusion Criteria: - Nausea and vomiting of pregnancy Exclusion Criteria: - Other medical condition causing nausea and vomiting of pregnancy

Drug:
• vitamin B6
high dose of vitamin B6
• vitamin B6
low vitamin B6

Locations
Country	Name	City	State
Indonesia	Dept. Obstetric Gynecology Univ. Indonesia	Jakarta

Sponsors *(2)*
Lead Sponsor	Collaborator
Showa University	University of Bologna

Indonesia,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Nausea and vomiting score		2 weeks
Secondary	Vitamin B6 concentration in nausea and vomiting of pregnancy		2 weeks